| CTRI Number |
CTRI/2025/07/090710 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective, observational, comparative study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO COMPARE THE EFFECTS OF IV NALBUPHINE AND IV LIGNOCAINE IN REDUCING THE BODY’S STRESS RESPONSE DURING LARYNGOSCOPY AND INSERTION OF A BREATHING TUBE (TRACHEAL INTUBATION). |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO EVALUATE THE EFFECTS OF IV
NALBUPHINE IN PREVENTING STRESS RESPONSE OF LARYNGOSCOPY AND
TRACHEAL INTUBATION IN COMPARISON TO IV LIGNOCAINE. |
| 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 Alpa Patel |
| Designation |
Professor |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka university |
| Address |
Department of anaesthesiology Shree krishna hospital Pramukh
swami medical college karamsad Anand Gujarat 388325 India
Anand
GUJARAT
388325
India |
| Phone |
9825084282 |
| Fax |
|
| Email |
alpamp@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pujan Patel |
| Designation |
Resident Anesthesiologist |
| Affiliation |
Pramukh swami medical college |
| Address |
Department of anaesthesiology Shree krishna hospital Pramukh
swami medical college karamsad Anand Gujarat 388325 India
Anand
GUJARAT
388325
India |
| Phone |
8469740719 |
| Fax |
|
| Email |
pujanrpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pujan Patel |
| Designation |
Resident Anesthesiologist |
| Affiliation |
Pramukh swami medical college |
| Address |
Department of anaesthesiology Shree krishna hospital Pramukh
swami medical college karamsad Anand Gujarat 388325 India
Anand
GUJARAT
388325
India |
| Phone |
8469740719 |
| Fax |
|
| Email |
pujanrpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Shree Krishna Hospital Pramukh Swami Medical College Gokal
Nagar, Karamsad, Dist. Anand- 388 325 |
|
|
Primary Sponsor
|
| Name |
Shree Krishna Hospital |
| Address |
Department of anaesthesiology Shree krishna hospital Pramukh
swami medical college karamsad Anand Gujarat 388325 India |
| Type of Sponsor |
Private medical college |
|
|
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 Pujan Patel |
Shree Krishna Hospital |
Department of Anesthesiology Shree Krishna Hospital Pramukh
Swami Medical College Gokal Nagar, Karamsad, Dist. Anand
Anand
GUJARAT
388325
India
Anand
GUJARAT |
8469740719
pujanrpatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - 2 |
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 |
| Comparator Agent |
IV administration of Nalbuphine vs Lignocaine |
Comparison of effects on the
hemodynamic response to
laryngoscopy and intubation
with administration of IV Nalbuphine
vs IV Lignocaine |
| Intervention |
To prevent hemodynamic stress
response to laryngoscopy and
intubation |
Comparison of effects on the hemodynamic response to laryngoscopy and intubation with administration of IV Nalbuphine vs IV Lignocaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing elective surgeries requiring general anesthesia and tracheal intubation
2. Patients Belonging to ASA grade 1 2 and 3 |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate
2. Patients belonging to ASA grading 4,5
3. Patient with severe renal, hepatic, cardiovascular or respiratory disease
4. Pregnant and Lactating women
5. Patient with history of allergies to the related drugs.
6. Patients with Difficult airway and Laryngoscopy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To prevent hemodynamic stress response to
laryngoscopy and intubation |
0 to 10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Study the dose sparring effect of IV nalbuphine on the amount of propofol used
during induction of General Anaesthesia.
2. To study Hemodynamic stability in patients with different co morbidities |
0 to 10 mins |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="1"
Months="0"
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
|
This observational study, conducted at Shree Krishna Hospital, Karamsad, aims to compare the efficacy of intravenous nalbuphine (0.2 mg/kg) versus lignocaine (1.5 mg/kg) in preventing the stress response—such as tachycardia and hypertension—associated with laryngoscopy and tracheal intubation in patients undergoing elective surgery under general anaesthesia. With a sample size of 54 ASA grade I–III patients aged 18–65 years, the study investigates not only the primary outcome of hemodynamic stability during and after intubation but also the secondary outcomes, including nalbuphine’s potential to reduce propofol requirements. Participants are randomized into two groups, and standard anaesthetic protocols are followed, with vital signs monitored for 10 minutes post-intubation. Literature review suggests that while nalbuphine is effective in attenuating the pressor response with fewer side effects and better cardiovascular stability, fentanyl may be more potent in some cases. Lignocaine has also been shown to blunt reflexes but with less consistent hemodynamic control. The study is ethically approved, involves no additional patient cost, and maintains strict confidentiality. Findings are expected to contribute to optimizing anaesthetic protocols, guiding drug selection, and improving patient outcomes through better stress response management during airway manipulation. |