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CTRI Number  CTRI/2023/01/049137 [Registered on: 23/01/2023] Trial Registered Prospectively
Last Modified On: 20/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative study to evaluate the effect of intravenous fentanyl and nalbuphine on hemodynamic stress response to laryngoscopy and endotracheal intubation in patients undergoing elective surgery under general anesthesia. 
Scientific Title of Study   A comparative study to evaluate the effect of fentanyl and nalbuphine on hemodynamic stress response to laryngoscopy and endotracheal intubation under general anesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun yadav 
Designation  Third year Anesthesia resident 
Affiliation  Maharshi Markandeshwar Institute of Medical Sciences and Research 
Address  Dept. of Anesthesia MM Institute of medical sciences and research centre, Mullana, Ambala Haryana India
Mullana
Ambala
HARYANA
133207
India 
Phone  9713707371  
Fax    
Email  arunyadav931@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Babita Ramdev 
Designation  Professor 
Affiliation  MM Institute of Medical Sciences and Research Centre, Mullana, Ambala 
Address  Dept. of Anesthesia MM Institute of medical sciences and research centre, Mullana, Ambala Haryana India

Ambala
HARYANA
133207
India 
Phone  7888554917  
Fax    
Email  babitaramdev30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Babita Ramdev 
Designation  Professor 
Affiliation  MM Institute of Medical Sciences and Research Centre, Mullana, Ambala 
Address  Dept. of Anesthesia MM Institute of medical sciences and research centre, Mullana, Ambala Haryana India

Ambala
HARYANA
133207
India 
Phone  7888554917  
Fax    
Email  babitaramdev30@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anesthesia MM Institute of medical sciences and research centre, Mullana, Ambala Haryana  
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  MM Institute of medical sciences and research centre, Mullana, Ambala Haryana  
Type of Sponsor  Private 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 
Arun yadav  MM Institute of medical sciences and research centre  Dept. of Anesthesia MM Institute of medical sciences and research centre, Mullana, Ambala Haryana 133207 India
Ambala
HARYANA 		 9713707371

arunyadav931@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, MMIMSR, Mullana, Ambala  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  Endotracheal intubation for general anaesthesia   Intravenous nalbuphine (0.2 mg/kg) versus fentanyl (2 mcg/kg) before endotracheal intubation was given and response to endotracheal intubation was assessed during the intra operative period.  
Comparator Agent  Fentanyl  Injection fentanyl 2 mcg/kg IV prior to endotracheal intubation.  
Comparator Agent  Nalbuphine  Injection nalbuphine 0.2 mg/kg IV prior to endotracheal intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients belonging to ASA grade 1 or 2.
2 Patients undergoing elective surgery under general anaesthesia.  
 
ExclusionCriteria 
Details  1 Patients refusal for the procedure.
2 Contraindications to general anaesthesia.
3 Patients belonging to ASA grade 3 or above.
4 Patients undergoing emergency surgery.
5 Patients with history of allergy to opioids.  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Intravenous fentanyl and nalbuphine on SBP, DBP AND MAP during laryngoscopy and endotracheal intubation.   Intra operative during intubation  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Intravenous fentanyl and nalbuphine on heart rate during laryngoscopy and endotracheal intubation.   Intra operative during intubation  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   30/01/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/02/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The purpose of the study is to compare the effects of intravenous fentanyl and nalbuphine on haemodynamic response to laryngoscopy and intubation in ASA grade 1 or 2 undergoing surgery under general anaesthesia.  
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