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CTRI Number  CTRI/2020/11/029347 [Registered on: 25/11/2020] Trial Registered Prospectively
Last Modified On: 27/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of drugs i.e. intravenous nalbuphine and dexmedetomidine as premedication on emergence agitation in adult patients undergoing abdominal surgery. 
Scientific Title of Study   Comparison of effect of intravenous nalbuphine and dexmedetomidine as premedication on emergence agitation in adult patients undergoing abdominal surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gurwinder Kaur 
Designation  PG Resident 
Affiliation  G.G.S. Medical College and Hospital, Faridkot. 
Address  Department of Anaesthesia, G.G.S. Medical College and Hospital, Faridkot. 151203 PUNJAB India
Department of Anaesthesia, G.G.S. Medical College and Hospital, Faridkot. 151203 PUNJAB India
Faridkot
PUNJAB
151203
India 
Phone  9464311295  
Fax    
Email  gkmalhi95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarvjeet Kaur 
Designation  Professor 
Affiliation  G.G.S. Medical College and Hospital, Faridkot.  
Address  Department of Anaesthesia, G.G.S. Medical College and Hospital, Faridkot. 151203 PUNJAB India
Department of Anaesthesia, G.G.S. Medical College and Hospital, Faridkot. 151203 PUNJAB India
Faridkot
PUNJAB
151203
India 
Phone  9915680508  
Fax    
Email  drsarvjeetk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarvjeet Kaur 
Designation  Professor 
Affiliation  G.G.S. Medical College and Hospital, Faridkot.  
Address  Department of Anaesthesia, G.G.S. Medical College and Hospital, Faridkot. 151203 PUNJAB India
Department of Anaesthesia, G.G.S. Medical College and Hospital, Faridkot. 151203 PUNJAB India
Faridkot
PUNJAB
151203
India 
Phone  9915680508  
Fax    
Email  drsarvjeetk@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, GGS Medical College Faridkot 
 
Primary Sponsor  
Name  GGS Medical College and Hospital Faridkot Punjab 
Address  Department of Anaesthesia GGS Medical College and Hospital Faridkot 151203 Punjab 
Type of Sponsor  Other [Guide has ensured all the facilities for the study are available in the institution.] 
 
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 
Gurwinder Kaur  GGS Medical College and Hospital, Faridkot, Punjab  Department of Anaesthesia GGS Medical College and Hospital, Faridkot, 151203 Punjab
Faridkot
PUNJAB 		 9464311295

gkmalhi95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of GGS Medical College and Hospital, Faridkot , Punjab  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F05||Delirium due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Injection dexmedetomidine given intravenously 15 minutes before surgery. 
Comparator Agent  Nalbuphine  Injection Nalbuphine given intravenously 15 minutes before surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients of age between 18 to 55 years, undergoing abdominal surgery under General anaesthesia (GA).
2. ASA I & II.
 
 
ExclusionCriteria 
Details  1. Duration of surgery ≤ 1 hour.
2. Patient having renal, hepatic, cardiovascular and cerebral dysfunction.
3. History of anaphylaxis or allergy to the study drugs
4. BM I >30 kg/m2.
5. Psychiatric disorders or drug abuse.
• Patients refused to participate in study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of IV nalbuphine and dexmedetomidine on incidence of EA.  Hourly monitoring till 12 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Severity of EA.
2. NRS score for Post Operative Pain (POP) assessment.
3. Hemodynamic variability.
4. Post operative total analgesic requirement.
5. Patient’s satisfaction.
6. Side effects if any.
 		 Hourly monitoring till 12 hours. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   27/11/2020 
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 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   Emergence agitation (EA) is one of the most common complications after general anaesthesia. EA comprises of agitation, confusion, disorientation or violent behaviour in the early phase of recovery from general anaesthesia. Nalbuphine and dexmedetomidine are the two drugs we are going to compare on the basis of incidence, severity, hemodynamic variability and side effects. This study will be having two groups with sample size of 40 in each group including both males and females of age between 18 to 55 years and excluding patients with history of anaphylaxis or allergy to the study drugs and patients refusing for consent etc. 
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