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CTRI Number  CTRI/2024/04/065626 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
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   Comparison of fentanyl and nalbuphine in attenuating blood pressure and heart rate during laryngoscopy in patients undergoing general anaesthesia. 
Scientific Title of Study   Comparative study of intravenous bolus doses of nalbuphine with fentanyl in attenuating hemodynamic response to laryngoscopy in patients undergoing nasal intubation for oral and maxillofacial surgery (OMFS) under general anesthesia  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubhangi 
Designation  Junior Resident  
Affiliation  Institute of Medical Sciences, BHU 
Address  Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  7903701788  
Fax    
Email  sipushubhangi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Atul Kumar Singh 
Designation  Associate Professor 
Affiliation  Institute of Medical Sciences, BHU 
Address  Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  8317010317  
Fax    
Email  atulksingh84@gmail.com  
 
Details of Contact Person
Public Query  
Name  Atul Kumar Singh 
Designation  Associate Professor 
Affiliation  Institute of Medical Sciences, BHU 
Address  Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  8317010317  
Fax    
Email  atulksingh84@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Nil 
Address  Institute of Medical Sciences Banaras Hindu University  
Type of Sponsor  Government 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 
Shubhangi  Faculty of Dental Sciences,IMS, BHU  Trauma Centre, Institute of Medical Sciences, BHU
Varanasi
UTTAR PRADESH 		 7903701788

sipushubhangi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   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  Intravenous bolus premeditation dose of nalbuphine   Administration of intravenous bolus dose of nalbuphine as premedication in patients undergoing maxillofacial surgeries to see their efficacy in attenuating hemodynamic response to laryngoscopy during nasal intubation  
Comparator Agent  Intravenous premeditation bolus dose of fentanyl   Effect of intravenous premedication bolus dose of nalbuphine will be compared with intravenous premedication bolus dose of fentanyl  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Undergoing nasal intubation in oral and maxillofacial surgery.
Patient belonging to American society of Anaesthesiologist physical 1 and 2. 
 
ExclusionCriteria 
Details  Age>60 or <18
Preoperative hypertension, coronary artery disease (CAD), cardiac conduction defects, congenial heart disease, hemodynamic instability and associated comorbidity.
Obesity ( body mass index >30 kg per square meter).
Mouth opening less than or equal to 2.5 fingers or inability to do laryngoscopy.
MPG grade 4.
Patients with nasal fracture.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Compare the efficacy between nalbuphine and fentanyl in attenuating hemodynamic response to laryngoscopy and nasal intubation.  Intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Compare Post operative sedation
Compare post operative pain. 		 Post operatively 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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/ Phase 4 
Date of First Enrollment (India)   19/05/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   General Anesthesia administration involves laryngoscopy and endotrachial intubation which are associated with the pressor response and can lead to tachycardia, hypertension and arrhythmias, which can be deleterious in both healthy and compromised patients and hence response needs to be suppressed.Nasal intubation is the commonest endotracheal intubation method practiced during general anaesthesia in oral and maxillofacial surgeries. This study is designed to compare the efficacy of nalbuphine and fentanyl in attenuation of haemodynamic response in patients undergoing nasal intubation under general anaesthesia. 
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