| CTRI Number |
CTRI/2025/06/088581 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on comparing efficacy of nebulized ketamine, betamethasone, and lignocaine for reducing postoperative sore throat, cough, and hoarseness of voice in elective surgery patients under general anaesthesia. |
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Scientific Title of Study
|
comparative efficacy of nebulized ketamine, betamethasone, and lignocaine for mitigating postoperative sore throat, cough, and hoarseness of voice in elective surgery patients under general anaesthesia - a double blind randomized controlled 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 |
NAZREEN BANU J |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
All India Institute Of Medical Sciences, Nagpur |
| Address |
Department of Anaesthesia, AIIMS NAGPUR, NAGPUR, MAHARASHTRA Department of Anaesthesia , AIIMS Nagpur, Maharashtra Nagpur MAHARASHTRA 441108 India |
| Phone |
6374446528 |
| Fax |
|
| Email |
nazreennishahussain@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR. AVINASH PRAKASH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute Of Medical Sciences, Nagpur |
| Address |
Department of Anaesthesia, AIIMS NAGPUR, NAGPUR, MAHARASHTRA Department of Anaesthesia , AIIMS Nagpur, Maharashtra Nagpur MAHARASHTRA 441108 India |
| Phone |
9999596845 |
| Fax |
|
| Email |
dravinash@aiimsnagpur.edu.in |
|
Details of Contact Person Public Query
|
| Name |
NAZREEN BANU J |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
All India Institute Of Medical Sciences, Nagpur |
| Address |
Department of Anaesthesia , AIIMS NAGPUR, NAGPUR, MAHARASHTRA Department of Anaesthesia , AIIMS Nagpur, Maharashtra Nagpur MAHARASHTRA 441108 India |
| Phone |
6374446528 |
| Fax |
|
| Email |
nazreennishahussain@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur. PINCODE:441108 |
|
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Primary Sponsor
|
| Name |
DR NAZREEN BANU J |
| Address |
DEPARTMENT OF ANAESTHESIA, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, MIHAN, DAHEGAON, NAGPUR, MAHARASHTRA |
| Type of Sponsor |
Other [OTHER [SELF]] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NAZREEN BANU J |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NAGPUR |
DEPARTMENT OF ANAESTHESIA, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, MIHAN, DAHEGAON, NAGPUR, MAHARASHTRA Nagpur MAHARASHTRA |
6374446528
nazreennishahussain@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: J00-J06||Acute upper respiratory infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NEBULIZATION WITH BETAMETHASONE |
ONE GROUP WILL BE NEBULIZED WITH BETAMETHASONE FOR MITIGATING POST OPERATIVE HOARSENESS, COUGH AND SORE THROAT IN ELECTIVE SURGERY PATIENTS UNDER GENERAL ANAESTHESIA |
| Intervention |
NEBULIZATION WITH KETAMINE |
ONE GROUP WILL BE GIVEN NEBULIZATION WITH KETAMINE FOR MITIGATING POST OPERATIVE HOARSENESS, COUGH AND SORE THROAT IN ELECTIVE SURGERY PATIENTS UNDER GENERAL ANAESTHESIA |
| Intervention |
NEBULIZATION WITH LIGNOCAINE |
ONE GROUP WILL BE GIVEN NEBULIZATION WITH LIGNOCAINE FOR MITIGATING POST OPERATIVE HOARSENESS, COUGH AND SORE THROAT IN ELECTIVE SURGERY PATIENTS UNDER GENERAL ANAESTHESIA |
| Comparator Agent |
NEBULIZATION WITH NORMAL SALINE |
ONE GROUP WILL BE NEBULIZED WITH NORMAL SALINE -PLACEBO AGENT FOR MITIGATING POST OPERATIVE HOARSENESS, COUGH AND SORE THROAT IN ELECTIVE SURGERY PATIENTS UNDER GENERAL ANAESTHESIA |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.All adult patients aged between 18 to 65 years.
2.Patients with American Society of Anaesthesiologists (ASA) physical status classes I or II.
3.Patients scheduled for elective surgery requiring general anaesthesia with endotracheal intubation.
4.Patients who provided informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.All adult patients aged below 18 and above 65 years.
2.Patients with American Society of Anaesthesiologists (ASA) physical status above classes II.
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of the incidence of postoperative sore throat, cough, and hoarseness of voice within the first 24 hours following surgery.
2.Comparison of the severity of postoperative sore throat, cough, and hoarseness of voice among patients receiving nebulised ketamine, betamethasone, or lignocaine
3.Haemodynamic variables (HR, BP, SpO2) will be monitored, compared before nebulisation before intubation and post extubation |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of the duration (in hours) of postoperative sore throat, cough, and hoarseness of voice among patients in each intervention group.
2.Identification and documentation of any adverse effects related to the administration of nebulised ketamine, betamethasone, or lignocaine.
3.Assessment of patient satisfaction with postoperative throat symptoms and overall comfort using a standardized satisfaction survey or questionnaire.
4.Comparison of patient satisfaction levels between the nebulised ketamine, betamethasone, and lignocaine intervention groups to identify differences in perceived effectiveness and comfort.
|
18 months |
|
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Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Postoperative sore throat (POST) is a common occurrence following general anaesthesia with endotracheal intubation although clinicians often regard it as a minor complication. The incidence of POST is estimated to be 21%–65% in different studies. POST although a self-limiting complication following general anaesthesia with endotracheal intubation, it continues to be an important concern for surgical patients. As perioperative physicians, we are entrusted with the deeds of decreasing the sufferings of surgical patients. When reviewing the literature for the prevention of POST, some non-pharmacological and pharmacological interventions have been tried with varying success rates. Nebulization is inexpensive, quick, convenient, and easy to administer also, which made this, the route of choice. In our study, we compared the effectiveness of ketamine and magnesium sulphate nebulization on POST . The following factors influences the incidence of post-operative sore throat, which includes Experience of anaesthetist, adequate relaxation of the patient, careful insertion technique, soft suction catheters, smaller tracheal tubes, minimal cuff-tracheal contact area, monitoring and adjustment of intracuff pressure and avoidance of local anaesthetic /steroid lubricants. Various methods to alleviate postoperative sore throat has been reported in the literature. There are variable causes that can aggravate sore throat such as patient related factors, type of anaesthesia and type of surgery. Steroids are commonly used intraoperatively to reduce airway oedema and inflammation. Ketamine gargling has been used for sore throat but due to risk of aspiration, palatability limits its usage. Lignocaine jelly applied over tracheal tube cuff may reduce sore throat but because of inaccuracy of instilled drug and short duration of action some additional management has to follow for postoperative sore throat. Nebulization of lignocaine and ketamine prior to general anaesthesia confers good tube tolerability to patient as entire air passages is anaesthetized and attenuates sore throat after extubation Ketamine has pharmacological properties such as analgesia, anaesthesia, and sympathetic action. Some studies have been done which show that ketamine decreases tumour necrosis factor-alpha production in a lipopolysaccharide-induced rat model of sepsis, and it demonstrates a protective mechanism in lung injury by decreasing the expression of inducible nitric oxide synthase and by its anti-inflammatory properties. Studies have suggested its role in endotoxin-induced tissue injury. It has been observed that local use of this drug through the nasal, oral, and rectal routes is both effective and plausible in ant nociception and anti-inflammatory cascade. Local anaesthetic drugs act by producing a reversible block to the transmission of peripheral nerve impulses. Lignocaine is used commonly for infiltration in concentrations of 0.5%–1.0% and for peripheral nerve blocks if an intermediate duration is required. Lidocaine 2%–4% is used by many anaesthetists as a topical solution for anaesthesia of the upper airway before awake intubation.
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