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CTRI Number  CTRI/2021/12/038957 [Registered on: 27/12/2021] Trial Registered Prospectively
Last Modified On: 03/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparatively studying the effect of addition of ketamine or magnesium sulphate when added to bupivacaine in scalp block for pain relief in head surgeries.  
Scientific Title of Study   Comparison of preemptive analgesic efficacy of ketamine versus magnesium sulphate as adjuvant to bupivacaine for scalp block in patients undergoing supratentorial craniotomies: A prospective double blind randomized comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakshi Kadian 
Designation  Senior resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesiology and critical care, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249201
India 
Phone  09610058068  
Fax    
Email  sakshi27wow@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Gupta 
Designation  Associate Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesiology and Critical care,AIIMS Rishikesh

Dehradun
UTTARANCHAL
249201
India 
Phone  9811894899  
Fax    
Email  priyanka.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sakshi Kadian 
Designation  Senior resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesiology and critical care, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249201
India 
Phone  09610058068  
Fax    
Email  sakshi27wow@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and critical care, AIIMS Rishikesh 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Department of Anesthesiology and critical care, AIIMS Rishikesh 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Sakshi  All India Institute of Medical Sciences  Neurosurgical operation theatre, Level 6, B block
Dehradun
UTTARANCHAL 		 9610058068

sakshi27wow@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh 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 
Comparator Agent  Bupivacaine alone  12 ml of 0.5% bupivacaine, with 6 ml normal saline as placebo will be taken thus making total volume of 18 ml of drug for scalp block. 
Intervention  Ketamine addition  2mg/kg ketamine will be added to 12 ml 0.5 % bupivacaine. The total amount of drug taken will be 18 ml and it will be prepared by adding the normal saline for the remaining volume.This solution will then be used for scalp block. 
Intervention  Magnesium sulphate addition  250 mg of 10%Mgso4 will be added to 12 ml 0.5 % bupivacaine and 3.5 ml of normal saline, thus making total volume of 18 ml of drug, which will then be used for scalp block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I-III patients in the age group mentioned above with Glasgow coma scale 13-15 who are scheduled for elective supratentorial craniotomies will be included in our study. 
 
ExclusionCriteria 
Details  Below mentioned are our exclusion criteria:
1. Refusal of consent.
2. Local infection at the injection site
3. Patients with coagulation disorders/thrombocytopenia
4. Patients with Glasgow Coma Scale (GCS) <13preoperatively.
5. Patients having psychotic disorders/ substance abuse.
6. Patients with poor cognitive functions preoperatively.
7. Patients with chronic headache or on analgesics for long duration.
8. Known or suspected allergy to study drugs.
9. Patients with uncontrolled hypertension, uncontrolled diabetes mellitus or heart disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Heart rate and mean arterial blood pressure following pin application in supratentorial craniotomies.  At 1 minute and 5 minutes following head pin application. 
 
Secondary Outcome  
Outcome  TimePoints 
Brain relaxation score following opening of dura mater.  At dura mater opening 
Demand of first analgesic drug intraoperatively( more than 20% increase in heart rate and meaan blood pressure )  Time when heart rate and mean blood pressure increase by more than 20% for the first time intraoperatively 
Perfusion index values intraoperatively and postoperatively  Baseline after shifting patient to operating table, 1 minute after induction of anesthesia, 5 minutes after induction of anesthesia, during scalp block, 1 minute after scalp block, 5 minutes after scalp block,during head pin application, 1 minute after head pin application, 5 minutes after head pin application,during incision, 1 minute after incision, 5 minutes after incision, every 30 minutes after incision until skin closure, during skin closure 
Dose of rescue drug like propofol, fentanyl or beta blockers to treat hemodynamic fluctuations(heart rate and mean blood pressure change more than 20% of the baseline)  At any time point 
Total analgesic consumption (opioid/ NSAIDS) intraoperatively and postoperatively up to 24 hours.   From entering in operating room upto 24 hours 
Blood sugar levels till 24 hours postoperatively  Baseline after shifting patient to operating table, immediately following induction, 10 min after head pin insertion, end of surgery, at extubation, 2 hours post operatively and 24 hours post operatively 
Critical-Care Pain Observation Tool (CPOT) score  1 hour postoperatively, 4 hours postoperatively, 8 hours postoperatively, 16 hours postoperatively and 24 hours postoperatively.  
Time of demand for first analgesic drug postoperatively-extubated patients complain of pain and presence of CPOT2 in both extubated and ventilated patients  Time when patient needs analgesia for the first time in post operative period 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2022 
Date of Study Completion (India) 01/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Neurosurgeries are associated with immense pain in patients, hence scalp block is given intraoperatively to decrease 

the demand of analgesic drugs and to maintain hemodynamic stability. This analgesic activity of scalp block 

can be enhanced by adding various additives with local aesthetics. Thus we compared the  analgesic activity of 

ketamine versus magnesium sulphate as adjuvant to bupivacaine for scalp block in patients undergoing 

supratentorial craniotomies. It was double blind radomized comparative study. Total amount of drug in all the three 

groups was 18ml. In group K  patients were given scalp block using 12 ml 0.5 % bupivacaine with 2mg/kg ketamine. The total amount of drug taken was 18 ml and it was prepared by adding the normal saline for the remaining volume.In group M patients 
were given scalp block using 12 ml 0.5 % bupivacaine with 250 mg of 10% magnesium sulphate  and 3.5 ml of normal 
saline, thus making total volume of 18 ml of drug.In group C patients were given scalp block using 12 ml of 0.5% bupivacaine, with 6 ml normal saline as placebo, thus making total volume of 18 ml of drug.We compared heart rate, mean blood pressure at various time points, analgesic requirements intraoperatively and postoperatively, the value of pain scores intraoperatively and postoperatively. On statistical analysis,  further information about analgesic efficacy of scalp block in head surgery patients could be studied.
 
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