| CTRI Number |
CTRI/2026/01/100220 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Methadone in Reducing Hemodynamic Stress Response During Laryngoscopy and Endotracheal Intubation: A Single Group Interventional Study |
|
Scientific Title of Study
|
Evaluation of Methadone’s Role in Attenuating Hemodynamic Stress Response During Laryngoscopy and Endotracheal Intubation: A Single Group Interventional 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 |
Subodh Kumar Gupta |
| Designation |
Junior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH |
| Address |
Department of anaesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8809493791 |
| Fax |
|
| Email |
guptasubodh75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajit Kumar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical sciences Rishikesh |
| Address |
Department of anaesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9910789377 |
| Fax |
|
| Email |
ajit.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajit Kumar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical sciences Rishikesh |
| Address |
Department of anaesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9910789377 |
| Fax |
|
| Email |
ajit.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, All India institute of medical science, Rishikesh |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subodh Kumar Gupta |
AIIMS Rishikesh |
Level 6, Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra road
Dehradun
UTTARANCHAL |
8809493791
guptasubodh75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJ Methadone 0.3 mg/kg |
Inj Methadone 0.3 mg/kg will be given 8 minutes prior intubation and patient will be monitored for 10 minutes after intubation to see intubation stress response |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients Age 18-60
2. Patients with American Society of Anesthesiologists(ASA) physical status class 1 or 2
3. Gender-both male and female
4. Patient willing to participate
5. BMI less than 30
6. Modified Mallampati Score I & II
|
|
| ExclusionCriteria |
| Details |
1. Patients’ refusal
2. patients undergoing emergency surgery
3. patients with American society of anesthesiologists(ASA) physical status class III & IV
4. Known allergy or hypersensitive reaction to Methadone
5. contraindications to Methadone
6. significant renal or liver dysfunction
7. preoperative opioid dependence or chronic opioid use
8. Pregnant and Nursing Women.
9. History of difficult intubation, Intubation time more than 20 seconds or more than one attempt or modified Mallampati score III & IV.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of methadone in reducing sympathoadrenal response during laryngoscopy and endotracheal intubation in adult patients undergoing general anesthesia |
T0- baseline
T1- pre induction
T2-Pre intubation
T3- 1 min after intubation
T4 -3 min after intubation
T5- 5 min after intubation
T6- 7 min after intubation
T7- 10 min after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of methadone in reducing acute postoperative pain score measured by NRS scale |
from time of extubation to 24 hours post operative period |
| To identify any potential adverse effects associated with intravenous methadone use within 24 hours postoperatively |
within 24 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The patients will be first assessed in the pre-anesthesia clinic (via history taking, through clinical examination, and routine investigations. The ratio of pain intensity will be recorded in response to the question, rate your worst pain using an 11-point numeric rating scale (NRS) (where 0 indicates no pain and 10 indicates worst pain). The study protocol will be explained to the patient and informed written consent will be obtained and patient would be allowed to ask doubts regarding the study and can withdraw from the study at any point of time. Standard institute guidelines will be followed for fasting and premedication. All the patients will be shifted to a preoperative area 1 hour before operation time. After cross-checking the patient details, confirming the compliance of the preoperative order the patient will be shifted into the operation theater. standard monitoring will be done and baseline heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation and ECG and modified Ramsay sedation score will be recorded and monitored. An 18G IV infusion line will start, and all patients will be hydrated with approximately 6-8 m/kg of normal saline before induction. All patients will be oxygenated with 100% oxygen for 3 min & INJ Methadone 0.3mg/kg (over 1 min) & wait for 3-5min, Propofol 1% solution, 1.5 mg/kg body weight (over 1 min) intravenously will be given. After ensuring induction and check ventilation, Vecuronium bromide 0.1 mg/kg body weight would be administered. The patient will be ventilated for 4 min and Endotracheal intubation will be done with cuffed endotracheal tube by an experienced anesthesiologist with 3 years of experience. After confirming for bilateral equal air entry, the endotracheal tube will be fixed and normocapnic ventilation will start with sevoflurane maintenance in a titrating way.EtCO2 monitoring & hemodynamic parameters (HR, BP, MAP, SPO2, ECG) will be recorded at the below mentioned time. T2-Pre intubation T3- 1 min after intubation T4 -3 min after intubation T5- 5 min after intubation T6- 7 min after intubation T7- 10 min after intubation After that, during the perioperative period BP, HR, MAP, ETCO2 & SPO2 will be monitored at 5 min intervals. Additional dose of skeletal muscle relaxant i.e., vecuronium bromide and rescue analgesia Inj paracetamol 1gm will be given. Inj ondansetron will be given 30 min before the end of surgery. During the surgery, any adverse event like 27 bradycardia, tachycardia or arrhythmia would be recorded. Bradycardia will be treated with inj atropine 0.6 mg & hypotension with normal saline & mephenteramine. At the end of the surgery, neuromuscular blockade will be reversed by inj neostigmine 50mcg/kg and inj glycopyrrolate 10mcg/kg. Extubation will be performed following standard extubation criteria recovery. post-operatively pain will be assessed using NUMERICAL RATING SCALE at the following periods: pre-operatively and 1, 2, 6, 12, and 24 hours postoperatively. If patients’ pain score is 4 or higher then they will receive Inj PCM 1 gm twice to thrice daily. Postoperative sedation score will be evaluated by Modified Ramsay Sedation Scale |