FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/103424 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   All the patients who will be posted for lower segment caesarean section surgeries, for subarachnoid block, we will be using Fentanyl versus Clonidine to Bupivacaine intrathecally. 
Scientific Title of Study   Comparison of Fentanyl versus Clonidine as an adjuvant to Bupivacaine for lower segment caesarean section surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogita Sorte 
Designation  Associate Professor 
Affiliation  Peoples College of Medical Sciences and Research Centre 
Address  A/16, BMHRC Campus, Raisen Bypass road, Karond, Bhopal.

Bhopal
MADHYA PRADESH
462038
India 
Phone  9806179234  
Fax    
Email  yogitanimje84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogita Sorte 
Designation  Associate Professor 
Affiliation  Peoples College of Medical Sciences and Research Centre 
Address  A/16, BMHRC Campus, Raisen Bypass road, Karond, Bhopal.

Bhopal
MADHYA PRADESH
462038
India 
Phone  9806179234  
Fax    
Email  yogitanimje84@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yogita Sorte 
Designation  Associate Professor 
Affiliation  Peoples College of Medical Sciences and Research Centre 
Address  A/16, BMHRC Campus, Raisen Bypass road, Karond, Bhopal.

Bhopal
MADHYA PRADESH
462038
India 
Phone  9806179234  
Fax    
Email  yogitanimje84@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Peoples College of Medical Sciences and Research Centre 
Address  Department of Anaesthesiology, Peoples College of Medical Sciences and Research Centre, Bhopal, 462037 
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 Yogita Sorte  Peoples College of Medical Sciences and Research Centre  Department of Anaesthesiology
Bhopal
MADHYA PRADESH 		 9806179234

yogitanimje84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Peoples College of Medical Sciences and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine plus Fentanyl in one group. Bupivacaine plus Clonidine in other group. Group F: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Fentanyl 10 microgram. Group C: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Clonidine 5 mcg.   Group F: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Fentanyl 10 microgram. Group C: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Clonidine 5 mcg. 
Intervention  Bupivacaine plus Fentanyl in one group. Bupivacaine plus Clonidine in other group.  Group F: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Fentanyl 10 microgram. Group C: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Clonidine 5 mcg. 
Intervention  In our present study, we use intrathecal Fentanyl in one group and intrathecal Clonidine in other group.  Patients will be shifted to operating room in left lateral position. A wedge will be kept under the right buttock to give a lateral tilt to the uterus. NIBP, pulse oxymeter and ECG will be connected to the patient. Base line SBP, DBP, MAP, Pulse rate, Respiratory rate and oxygen saturation will be recorded. Patients will be canulated 18G iv cannula and preloaded with 20 ml per kg RL. Patient will be placed in left lateral position. The L3-L4 inter space will be identified and 25G Quincke spinal needle will be introduced through midline approach. After confirming free flow of CSF the prepared solution will be injected. The patients will be made to lie supine immediately after injection and left lateral tilt will be provided by wedge under right buttock.Group F: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Fentanyl 10 microgram. Group C: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Clonidine 5 mcg. 
Comparator Agent  In our present study, we use intrathecal Fentanyl in one group and intrathecal Clonidine in other group.  Group F: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Fentanyl 10 microgram. Group C: Patients received 2.0 ml of 0.5% hyperbaric Bupivacaine (10 mg) plus Clonidine 5 mcg.Patients will be shifted to operating room in left lateral position. A wedge will be kept under the right buttock to give a lateral tilt to the uterus. NIBP, pulse oxymeter and ECG will be connected to the patient. Base line SBP, DBP, MAP, Pulse rate, Respiratory rate and oxygen saturation will be recorded. Patients will be canulated 18G iv cannula and preloaded with 20 ml per kg RL. Patient will be placed in left lateral position. The L3-L4 inter space will be identified and 25G Quincke spinal needle will be introduced through midline approach. After confirming free flow of CSF the prepared solution will be injected. The patients will be made to lie supine immediately after injection and left lateral tilt will be provided by wedge under right buttock. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Patients belonging to ASA grade I and II posted for caesarean surgery.
2. Patients between the age group 20-40 years. 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Patient having systemic cardiovascular, respiratory, hepatic, renal or central nervous system
disorders.
3. Patients with haemorrhagic disorders or patients who are on anticoagulant therapy.
4. Disease and deformities of spinal cord or vertebral column.
5. Patients with hypersensitivity to study drug, patients with known allergy or hypersensitivity to
local anaesthetics.
6. Patients with psychiatric illness and/or on any kind of sedative medication. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic stability, analgesia, satisfaction level of patient.  Duration of analgesia. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia.  Time of first rescue analgesia. 
 
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 4 
Date of First Enrollment (India)   20/02/2026 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   We compare the two groups of patients posted for lower segment caesarean section surgeries.  In one group we will be using Bupivacaine + 5 micrograms Clonidine and in other group we will be using Bupivacaine + 10 micrograms Fentanyl inthathecally. The total volume should not be more than 2.0 ml.
 
Close