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CTRI Number  CTRI/2023/01/048892 [Registered on: 11/01/2023] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparing two drugs midazolam and fentanyl used in spinal anesthesia for prolonged pain relief post surgery in patients undergoing caesarean section 
Scientific Title of Study   Comparative Study of Analgesic Efficacy of Intrathecal Fentanyl versus Intrathecal Midazolam as Adjuvant to Hyperbaric Bupivacaine in Elective Caesarean Section - A Randomized Double Blind clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gandam Raju 
Designation  junior resident 
Affiliation  Sikkim Manipal institute of medical sciences 
Address  PG room 1 , department of Anesthesiology , central referral hospital , Sikkim Manipal institute of medical sciences , 5th mile , tadong , Gangtok
room 412 , PG hostel , Sikkim Manipal institute of medical sciences , 5th mile tadong , Gangtok
East
SIKKIM
737102
India 
Phone  9620301010  
Fax    
Email  drrajugandham@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B K Gandhi 
Designation  Professor and HOD 
Affiliation  Sikkim Manipal institute of medical sciences 
Address  Department of Anesthesiology ,central referral hospital , Sikkim Manipal institute of medical sciences , 5th mile , tadong , Gangtok
staff Quarters, Sikkim Manipal institute of medical sciences , 5th mile tadong , Gangtok
East
SIKKIM
737102
India 
Phone  9831779215  
Fax    
Email  colbkg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr B K Gandhi 
Designation  Professor and HOD 
Affiliation  Sikkim Manipal institute of medical sciences 
Address  Department of Anesthesiology ,central referral hospital , Sikkim Manipal institute of medical sciences , 5th mile , tadong , Gangtok
staff Quarters, Sikkim Manipal institute of medical sciences , 5th mile tadong , Gangtok
West
SIKKIM
737102
India 
Phone  9831779215  
Fax    
Email  colbkg@gmail.com  
 
Source of Monetary or Material Support  
Sikkim Manipal Institute of medical sciences , 5th mile , tadong , gangtok , sikkim -737102 
 
Primary Sponsor  
Name  Sikkim Manipal Institute of medical sciences 
Address  5th mile , tadong , gangtok , sikkim 737102 
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 
Dr Gandam Raju  Central Referral Hospital , sikkim manipal institute of medical sciences   department of anaesthesiology , 5th mile , Tadong , Gangtok
East
SIKKIM 		 9620301010

drrajugandham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMIMS Institution 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  spinal anaesthesia   1mg midazolam (preservative free ) added to 1.8 ml of 0.5% hyperbaric Bupivacaine 
Comparator Agent  spinal anaesthesia  25 mcg fentanyl added to 1.8 ml of 0.5% hyperbaric Bupivacaine 
Intervention  Spinal Anesthesia  The patient included in the study after obtaining informed written consent shall be evaluated for as per protocol including requisite pre-operative clinical evaluation and investigation. In the operating room, a wide bore peripheral intravenous access will be secured with 18G cannula. On arrival to the operating room, routine monitoring devices will be attached and baseline blood pressure, ECG and pulse oximetry values will be recorded. All patients will be preloaded with Ringer’s lactate solution at 15 ml/kg before spinal anesthesia. Dural puncture will be performed preferably at L3–L4 interspace with a 25G Quinke spinal needle in the sitting position by an anesthesiologist who was not involved in the patient care. Patients will be divided into two groups, Group A and Group B. Group A shall receive 1.8 ml of 0.5%hyperbaric bupivacaine with 25mcg of fentanyl and Group B shall receive 1.8 ml of 0.5% hyperbaric bupivacaine with 1 mg of preservative free midazolam. The study starts at the time of administration of anesthetic drug with its adjuvant and ends after 12 hrs. post-operatively. Onset of analgesia will be assessed initially at 0,1,2,3,4,5 minutes for onset of analgesia and then after every 30 minutes interval till end of surgery. Post-operatively pain will be assessed every one hour till 12 hours using Numerical Pain Intensity Score (NRS) and Verbal Pain Intensity Score (VRS) . Post operative Rescue analgesia: Patient will be monitored for 12 hrs. for pain. If VRS pain score of the patient is moderate or more and NRS score more than 5 then, Injection Diclofenac will be administered initially and subsequent pain management will be done with Injection Paracetamol 1 gram SOS till end of the study (12hrs post-operatively). No Narcotic analgesics will be used 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.ASA physical status I
2.ASA physical status II
3.Age from 18-35 years
4.Scheduled to undergo elective caesarean section under spinal anesthesia 
 
ExclusionCriteria 
Details  ASA III or IV patients.
● Patients’ refusal for spinal anesthesia.
● Patients physically dependent on narcotics or benzodiazepine.
● Patients with history of drug allergy to fentanyl and midazolam
● Patients with gross spinal abnormality, localized skin sepsis, haemorrhagic diathesis or neurological involvement/ diseases and any contraindication for spine.
● Head injury cases.
● Patients with cardiac, pulmonary, hepatic or renal disorders.
● Patients with peripheral neuropathy.
● Patients having inadequate sub arachnoid blockade and who are later supplemented by general anesthesia.
● Chronic pain at puncture site.
● Patients who are unable to communicate. 
 
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 study and compare the Onset, Duration of Analgesia
• Consumption of additional Analgesics in first Post-Operative 12 Hours 		 12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To study Hemodynamic changes
• Sedative Effect on Mother (Ramsay sedation score) and on New Born (APGAR Score)
• Associated adverse effect during the study period (Nausea, Vomiting, shivering, Pruritis, Sedation, Hypotension, Bradycardia Hypersensitive Reaction, Respiratory Depression 		 12 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2023 
Date of Study Completion (India) 01/02/2024 
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   none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
primary purpose of the study :
To Compare  Analgesic Efficacy of Intrathecal Fentanyl versus Intrathecal Midazolam as Adjuvant in spinal anesthesia in Elective Caesarean Section for period of 12 hours
study hypothesis:
midazolam may provide better analgesia than intrathecal fentanyl 
 
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