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CTRI Number  CTRI/2025/10/096277 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 19/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to Compare Three Medicines i.e., Furosemide and Salty Water (3 percent and 0.9 percent sodium chloride) given via steam inhalation before surgery to prevent Sore Throat in patients undergoing Keyhole (laparoscopic) Surgery for Uterus Removal under General Anaesthesia 
Scientific Title of Study   Comparison of Pre-Operative Nebulisation with Furosemide, 3 Percent Sodium Chloride and 0.9 Percent Sodium Chloride in Prevention of Post-Operative Sore Throat in Patients undergoing Total Laparoscopic Hysterectomy under General Anaesthesia: A Double-Blinded Randomised Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adita Sharma 
Designation  Post Graduate Student 
Affiliation  Institute of Medical Sciences and SUM Hospital 
Address  Department of Anaesthesiology and Critical care first floor IMS and SUM Hospital Siksha O Anusandhan K8 Kalinga Nagar Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  7378662235  
Fax    
Email  draditasharma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajib Lochan Samal 
Designation  Associate Professor 
Affiliation  Institute of Medical Sciences and SUM Hospital 
Address  Department of Anaesthesiology and Critical care first floor IMS and SUM Hospital Siksha O Anusandhan K8 Kalinga Nagar Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  8763763798  
Fax    
Email  samal.rajib2013@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajib Lochan Samal 
Designation  Associate Professor 
Affiliation  Institute of Medical Sciences and SUM Hospital 
Address  Department of Anaesthesiology and Critical care first floor IMS and SUM Hospital Siksha O Anusandhan K8 Kalinga Nagar Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  8763763798  
Fax    
Email  samal.rajib2013@gmail.com  
 
Source of Monetary or Material Support  
Institute of medical Sciences and SUM Hospital, Siksha O Anusandhan, Bhubaneswar, Khordha, Odisha, India, Pin 751003 
 
Primary Sponsor  
Name  Institute of medical sciences and SUM hospital 
Address  Institute of medical Sciences and SUM Hospital, Siksha O Anusandhan, Bhubaneswar, Khordha, Odisha, India, Pin 751003 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Adita Sharma  Institute of Medical Sciences and SUM Hospital  Department of Anaesthesiology Obstetrics and Gynaecology OT in Modular 1 complex Ground Floor Institute of Medical Sciences and SUM Hospital Siksha O Anusandhan Bhubaneswar
Khordha
ORISSA 		 7378662235

draditasharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Institute of Medical Sciences and SUM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pre operative Nebulisation with 4ml of 0.9 percent Normal Saline   Preoperative nebulisation will be administered 15 minutes before induction of anesthesia in the preoperative room with 4 ml of 0.9 percent Normal Saline by the OT pharmacist who is not a part of the study via a nebulisation mask connected to Ozocheck Smart Nebulizer of Medsource Ozone Biomedicals Pvt. Ltd. for 20 minutes. After nebulization, Acceptability Score will be assessed. Patients will then be transferred to the operation theatre, standard monitors will be applied and Intravenous access will be secured. General Anesthesia will be administered. Patient will be intubated with low pressure and high volume size 7 PVC ET tube by Direct laryngoscopy using size 3 MacIntosh blade by an experienced anesthesiologist and cuff will be inflated with air at pressure 24cm H2O. Maintenance of anesthesia will be done by targeted doses of Vecuronium and 1 MAC achieved by Isoflurane with 1 is to 1 air and oxygen and maintained normocarbia. At the end of surgery, neuromuscular blockade will be reversed and patient will be extubated. Post extubation patients will receive oxygen inhalation at the rate of 4-6Litre per minute via Hudson Face Mask. The incidence, severity and duration of Post Operative Sore Throat will be assessed using standardised four point scale (0-3) at 2 hours, 4 hours and 6 hours post operatively. Post operative nausea and vomiting will be documented similarly. 
Intervention  Pre operative Nebulisation with 4ml of 3 percent Normal Saline.  Preoperative nebulisation will be administered 15 minutes before induction of anesthesia in the preoperative room with 4 ml of 3 percent Normal Saline by the OT pharmacist who is not a part of the study via a nebulisation mask connected to Ozocheck Smart Nebulizer of Medsource Ozone Biomedicals Pvt. Ltd. for 20 minutes. After nebulization, Acceptability Score will be assessed. Patients will then be transferred to the operation theatre, standard monitors will be applied and Intravenous access will be secured. General Anesthesia will be administered. Patient will be intubated with low pressure and high volume size 7 PVC ET tube by Direct laryngoscopy using size 3 MacIntosh blade by an experienced anesthesiologist and cuff will be inflated with air at pressure 24cm H2O. Maintenance of anesthesia will be done by targeted doses of Vecuronium and 1 MAC achieved by Isoflurane with 1 is to 1 air and oxygen and maintained normocarbia. At the end of surgery, neuromuscular blockade will be reversed and patient will be extubated. Post extubation patients will receive oxygen inhalation at the rate of 4-6Litre per minute via Hudson Face Mask. The incidence, severity and duration of Post Operative Sore Throat will be assessed using standardised four point scale (0-3) at 2 hours, 4 hours and 6 hours post operatively. Post operative nausea and vomiting will be documented similarly. 
Intervention  Pre operative Nebulisation with Furosemide 30 mg (3ml) and 1ml of 0.9 percent Normal Saline to make a solution of 4ml  Preoperative nebulisation will be administered 15 minutes before induction of anesthesia in the preoperative room with Furosemide 30mg and 1 ml of 0.9 percent Normal Saline to make a solution of 4ml by the OT pharmacist who is not a part of the study via a nebulisation mask connected to Ozocheck Smart Nebulizer of Medsource Ozone Biomedicals Pvt. Ltd. for 20 minutes. After nebulization, Acceptability Score will be assessed. Patients will then be transferred to the operation theatre, standard monitors will be applied and Intravenous access will be secured. General Anesthesia will be administered. Patient will be intubated with low pressure and high volume size 7 PVC ET tube by Direct laryngoscopy using size 3 MacIntosh blade by an experienced anesthesiologist and cuff will be inflated with air at pressure 24cm H2O. Maintenance of anesthesia will be done by targeted doses of Vecuronium and 1 MAC achieved by Isoflurane with 1 is to 1 air and oxygen and maintained normocarbia. At the end of surgery, neuromuscular blockade will be reversed and patient will be extubated. Post extubation patients will receive oxygen inhalation at the rate of 4-6 Litre per minute via Hudson Face Mask. The incidence, severity and duration of Post Operative Sore Throat will be assessed using standardised four point scale (0-3) at 2 hours, 4 hours and 6 hours post operatively. Post operative nausea and vomiting will be documented similarly.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  1. Age more than 18 yrs
2. ASA I and ASA II class
3. MP grade 1 and 2
4. Neck Circumference less than 40cm
5. posted for elective Total Laparoscopic Hysterectomy surgery under General Anaesthesia
6. No History of URTI in 2 weeks prior to surgery and any respiratory disorders
 
 
ExclusionCriteria 
Details  1. Patient who are not willing to participate in the study
2. difficult airway
3. History of COPD or Respiratory disorders.
4. History of URTI within 2 weeks prior to surgery
5. more than 1 attempt or more than 30 seconds at intubation.
6. Surgery time more than 3hrs
7. known allergy to either drugs
8. smokers
9. obese patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence and severity of Post Operative Sore Throat in Patients undergoing Total Laparoscopic Hysterectomy under General Anaesthesia after giving Pre operative Nebulisation with Furosemide and 3% Normal Saline.  standardised four point scale (0-3) at 2 hours, 4 hours and 6 hours post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the acceptability of the drugs  standardised three point scale at 20 minutes from administration of nebulisation 
To compare the incidence & severity of Post Operative Nausea Vomiting with the two drugs  standardised three point scale (0-2) at 2, 4, 6 hours post operatively 
To compare the Cost Effectiveness of the two drugs  Upon Statistical Analysis 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   03/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [draditasharma@gmail.com].

  6. For how long will this data be available start date provided 30-03-2026 and end date provided 30-03-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Postoperative Sore Throat even though self limiting is one of the common complaints after endotracheal intubation causing patient dissatisfaction and disregard towards General Anaesthesia with an incidence as high as 60 percent
In Total Laparoscopic Hysterectomy, Pneumoperitoneum created at 10 to 15mmHg combined with the patient positioned in Trendelenburg with Lithotomy position leads to an increase in the intraabdominal pressure which moves the diaphragm cephalad leading to rise in intrathoracic pressure and peak airway pressure causing an increase in the ETT cuff pressure. When the ETT cuff pressure exceeds the tracheal mucosal perfusion pressure, tracheal mucosal erosion occurs. This factor has been attributed to post operative sore throat.
Furosemide, a loop diuretic which when used as aerosol inhalation decreases airway oedema while regulating inflammatory reactions. It decreases airway hyper-responsiveness. Furosemide was also used as an adjunctive therapy for COVID19 Respiratory Failure in adults requiring invasive mechanical ventilation.
Hyperneb (3 percent Normal Saline) Nebulisation has been used in the management of Bronchiolitis, Cystic Fibrosis, Bronchial Asthma and Bronchiectasis. It improves mucus rheology and reduces airway wall oedema.
Nebulization allows these medications to directly act on the respiratory mucosa leading to rapid and effective relief with lower drug concentrations and thus lesser side-effects.

This prospective randomized comparitive study will be conducted at IMS & SUM Hospital’s Obstetrics and Gynaecology OT over a period of 5 months after all necessary ethical approvals. In this study, females more than 18 years scheduled for Total Laparoscopic Hysterectomyand belonging to ASA class I or II will be included.
Before starting the study, informed consent will be taken before anaesthesia and surgery.
All the patients will be kept nil per oral for at least 8 hours for solid, 4 hours for liquid and 2 hours for clear fluid before the surgery. 
Eligible patients will be randomly divided into three groups of 48 each by computer-generated random numbers, concealment will be done by sealed envelopes as folded slips in the OTcomplex. These slips will be picked up by an independent observer (pharmacist) who will later prepare the drug solutions accordingly. Both the patient & anesthesiologist involved in the study will be blinded to the groups allocated. 
All patients will be thoroughly examined preoperatively which includes history, general physical examination, the pre-op vitals of the patient such as blood pressure, pulse, respiratory rate, ASA grading and systemic examination.
Preoperative nebulisation will be performed for all patients. Group F will be administered with 30 mg (3ml) Furosemide with 1 ml NS, Group H will be administered with 4ml of 3 percent Normal Saline (Hyperneb) and Group N (control group) will be administered with 4ml of 0.9 percent Normal Saline by the OT pharmacist who is not a part of the study. The study drugs will be administered to patients via a nebulisation mask connected to Ozocheck Smart Nebulizer of Medsource Ozone Biomedicals Pvt. Ltd. which has an Average Nebulization Rate of 0.2ml per min, 15 mins before induction of anesthesia. After nebulization, we will assess Acceptability Score for the study drugs.
Patients will then be transferred to the operation theatre, standard monitors will be applied (non-invasive blood pressure, electrocardiogram and pulse oximetry). 
Intravenous access will be secured with Ringer Lactate drip to be started at the rate of 5ml per kg per hr and to be tailored according of intraoperative requirements. Preoxygenation will be done with 10Litres per min 100 percent Oxygen for 3-5mins. 
Premedication will be given with Inj Midazolam 30mcg per kg I.V, Inj Fentanyl 2mcg per kg I.V and Inj Lignocaine 1.5mg per kg I.V. Patients will be induced with Inj Propofol at 2-2.5mg per kg and will be intubated with Vecuronium at a dose 0.1mg per kg after 4 mins of bag and mask ventilation.
Direct laryngoscopy will be performed using MacIntosh laryngoscope blade of size 3 by an experienced anesthesiologist. Endotracheal intubation will be done using sterile 7.0-mm internal diameter cuffed (low pressure and high volume) polyvinyl chloride endotracheal tube. ET tube cuff will be inflated with air and pressure will be measured and kept at 24 cmH2O, by pressure gauge.
Inj. Dexmedetomidine infusion will be started with loading dose of 1mcg per kg for 10 mins followed by 0.5mcg per kg per min infusion.
Maintenance of anesthesia will be done by 1 MAC achieved by Isoflurane with air and oxygen at a ratio of 1 is to 1. Muscle relaxation will be maintained using intermittent doses of Vecuronium at the rate of 0.02mg per kg at30-40mins intervals. Ventilation will be adjusted to maintain normocarbia (target EtCO2 30 to 40mmHg).
Inj. Dexmedetomidine infusion will be stopped 15 mins prior to end of surgery. Inj PCM 1gm infusion will be administered.
At the end of surgery, gentle oral suctioning will be done and neuromuscular blockade will be reversed with Sugammadex at the dose 2-4mg per kg once the patients achieve spontaneous respiration. Extubation will be done once patients attain adequate respiratory effort. 
Post extubation patients will receive oxygen inhalation at the rate of 4-6Litres per min via Hudson Face Mask. Within 30 mins of extubation, patients will be administered Inj Tramadol 100mg in 100ml NS infusion over 30 mins for post operative analgesia.
Patients will be monitored in the recovery room, with attention to development of Post operative sore throat and other complications. The incidence, severity and duration of POST will be assessed using standardised four point scale (0-3) at 2, 4, 6hrs post operatively. 
Post operative nausea and vomiting will be documented using standardised three point scale (0-2) at 2, 4, 6 hrs post operatively.
Data will be collected and recorded by observer who will be unaware of the group allocations. 
Statistical analysis will be performed to compare the outcomes between the two groups with primary aim to focus on incidence and severity of POST. Interval data will be summarized by mean and standard deviation in each of the group separately. Nominal data will be summarized as frequency and percentage and Ordinal data will be summarized as median and interquartile range.Ordinal data will be compared using Friedman Test, Nominal data will be compared using  Chi Square Test and Interval data will be compared using Repeated measure ANOVA Test.The statistically significant difference is considered as a P value less than 0.05.
Sample size has been calculated based on previous study of Thomas D, Bejoy R, Zabrin N, Beevi S taking the effect size of 0.8, alpha error of 5 percent and power of 80 percent. The calculated sample size for one group is 44 which is inflated to 48 by considering 10percent  drop out rate. Thus total sample size is calculated to be 144.


 
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