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CTRI Number  CTRI/2025/01/079737 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive
Other (Specify) [Different routes of drug administration]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the action of dexmedetomidine drug given through the nostrils vs blood on changes in heart rate and blood pressure during keyhole surgeries in adult patients. 
Scientific Title of Study   Comparison of effect of intravenous vs intranasal dexmedetomidine on stress response to pneumoperitoneum in adults undergoing laparoscopic surgery: a double blinded hospital based randomised clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VARSHA B SHETTY 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College, Belagavi  
Address  Department Of Anaethesiology, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9663835852  
Fax    
Email  drvarshashetty94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana A Gogate 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College, Belagavi  
Address  Department Of Anaethesiology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010 Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9844083030  
Fax    
Email  vandanagogate@gmail.com  
 
Details of Contact Person
Public Query
 
Name  VARSHA B SHETTY 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College, Belagavi  
Address  Department Of Anaethesiology, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9663835852  
Fax    
Email  drvarshashetty94@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi,Karnataka, India, 590010 
 
Primary Sponsor  
Name  Varsha B Shetty 
Address  Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka, India-590010  
Type of Sponsor  Other [Self] 
 
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 Varsha B Shetty  Jawaharlal Nehru Medical College, Belagavi   2nd Floor, Department of Anaesthesiology, JNMC, Nehru Nagar, Belagavi, Karnataka-10 Belgaum KARNATAKA
Belgaum
KARNATAKA 
9663835852

drvarshashetty94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee, Jawaharlal Nehru medical college, Belagavi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INTRANASAL DEXMEDETOMIDINE  After obtaining the approval of ethical committee, written informed consent will be taken from patients meeting the inclusion criteria after pre anaesthetic evaluation. Patients will be randomized based on computer generated randomization table into two groups of 32 each(Total 64). 10 minutes prior to shifting to OT, GROUP 1 will receive 1.5 mcg/kg of intranasal dexmedetomidine in undiluted form, prepared from parenteral preparation (100 µg/ml) using an atomizer(stat dose), equal volume to both nostrils in supine head down position while GROUP 2 will receive equivalent volume of distilled water intranasally (stat). Sedation status noted using Ramsay Sedation Scale in preoperative area. All patients to be induced with IV Inj. propofol 2mg/kg and IV succinylcholine 2mg/kg to facilitate tracheal intubation. Anaesthesia will be maintained with 50% O2-N2O mixture, isoflurane 1-1.2 MAC, loading dose of vecuronium 0.1mg/kg followed by top ups of 1/4th the loading dose. Hemodynamic parameters (MAP, SBP, DBP and HR) to be recorded at BASELINE(PRE-OP),5mins before insertion of ports(T0),at the time of insufflation of abdomen(TP) and then every 5 minutes for 30 minutes.(T5,T10,T15,T20,T25,T30).  
Comparator Agent  INTRVENOUS DEXMEDETOMIDINE  GROUP 2 will receive 0.5 mcg/kg of intravenous dexmedetomidine in diluted form, prepared from parenteral preparation (100 µg/ml), Immediately after intubation over 10 minutes while GROUP 1 patients will receive equivalent volume of Normal Saline infusion. Sedation status noted using Ramsay Sedation Scale in the preoperative area. All patients to be induced and anaesthesia to be maintained similar to GROUP 1. Hemodynamic parameters (MAP, SBP, DBP and HR) to be recorded at BASELINE(PRE-OP),5mins before insertion of ports(T0),at the time of insufflation of abdomen(TP) and then every 5 minutes for 30 minutes.(T5,T10,T15,T20,T25,T30). In both groups, cardiovascular changes will be managed either by increasing the dose of isoflurane or giving IV fentanyl 0.5mcg/kg top up. The anaesthesia personnel noting down the parameters would be blinded to the allotted group of the patient.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) ASA physical status 1 and II
2) Patients undergoing laparoscopic surgeries under general anaesthesia
3) Provides consent
 
 
ExclusionCriteria 
Details  1) Patient refusal or unable to give consent
2) ASA physical status III & above
3)Patients with nasal deformities.
4)Patients allergic to study drug.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To study the effect of intravenous vs intranasal dexmedetomidine on stress response to pneumoperitoneum in laparoscopic surgeries  Baseline(Preop),5 mins before Pneumoperitoneum(T0),At the time of Pneumoperitoneum(TP),and then every 5mins thereafter[5mins (T5),10mins (T10),15mins (T15),20mins (T20),25mins (T25),30mins (T30)] 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the side effects of study drug if any.  UPTO 6 HOURS POST OP. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 3 
Date of First Enrollment (India)   09/02/2025 
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="2"
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 - NO
Brief Summary  

 Laparoscopic surgeries have become popular due to several postoperative benefits allowing quicker recovery, less tissue damage, avoiding big surgical incision, shorter hospital stay with consequent reduction in health care cost.

        But anaesthetic management in these patients has become complicated due to cardiopulmonary changes occuring during laryngoscopy, intubation, pneumoperitoneum and patient position required for different laparascopic surgeries. Hence the postoperative benefits of laparoscopy should be balanced against the intra-operative risks.

             Various drug combinations have been used with variable success to attenuate the sympathetic responses like: deepening the level of anesthesia with higher concentration of inhalational and intravenous anaesthetics agents, high dose of opioids, antihypertensives and beta adrenergic blockers.

            Dexmedetomidine is an alpha 2 adrenergic agonist that is currently being widely used for titrating sedation. It has sedative and analgesic property without causing much respiratory depression. When used as an intravenous adjuvant, it attenuates stress response associated with laryngoscopy, intubation as well as for pneumoperitoneum in laparoscopic surgeries providing haemodynamic stability. However, adverse haemodynamic complications like hypotension, bradycardia and even cardiac arrest may have reduced the widespread use of intravenous dexmedetomidine. Moreover, Delayed recovery with intravenous dexmedetomidine is also documented due to its sedative effect. It has been suggested that alternative routes other than rapid intravenous delivery may help to minimise the adverse effects of Dexmedetomidine while maintaining the advantageous effect of attenuating the stress response to pneumoperitoneum.  Intranasal route is more convenient, effective, reduces first pass metabolism and has a high rate of patient acceptance.

       After obtaining the approval of ethical committee a total of 64 patients undergoing laparoscopic surgeries under General Anaesthesia will be included in the study.

       After having met inclusion and exclusion criteria and having obtained informed consent, patients will be randomized based on computer generated randomization table into two groups (32 each).

          GROUP 1: will receive 1.5 mcg/kg of intranasal dexmedetomidine 

          GROUP 2: will receive 0.5 mcg/kg of intravenous dexmedetomidine

Hemodynamic parameters will be monitored. Sedation status in both groups, will also be assessed using the Ramsay sedation scale (RSS) in the pre-operative area. All patients to be induced with IV Inj. propofol 2mg/kg and IV succinylcholine 2mg/kg to facilitate tracheal intubation. Anaesthesia will be maintained with 50% O2-N2O mixture, isoflurane 1-1.2 MAC, loading dose of vecuronium 0.1mg/kg followed by top ups of 1/4th the loading dose. Hemodynamic parameters (MAP, SBP, DBP and HR) will be recorded every 5 minutes.

  Hence, this study is planned to investigate the effect of intravenous vs intranasal dexmedetomidine on attenuation of hemodynamic changes that occur after creation of pneumoperitoneum in laparoscopic surgeries.

 
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