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CTRI Number  CTRI/2025/07/091178 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of butorphanol and dexmedetomidine added to spinal ropivacaine for pain relief during lower body surgery 
Scientific Title of Study   Comparative Evaluation of Intrathecal Butorphanol and Dexmedetomidine as an Adjuvant to Hyperbaric Ropivacaine in Subarachnoid Block. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apurva Tandon 
Designation  Post Graduate Resident 
Affiliation  School of Medical Sciences and Research Sharda University 
Address  Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida Gautam Budh Nagar Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  7006439748  
Fax    
Email  apurva.tandon@sharda.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Kumar Agarwal 
Designation  Professor 
Affiliation  School of Medical Sciences and Research Sharda University 
Address  Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida Gautam Budh Nagar Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9838706199  
Fax    
Email  manish.agarwal@sharda.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Apurva Tandon 
Designation  Post Graduate Resident 
Affiliation  School of Medical Sciences and Research Sharda University 
Address  Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida Gautam Budh Nagar Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  7006439748  
Fax    
Email  apurva.tandon@sharda.ac.in  
 
Source of Monetary or Material Support  
School of Medical Sciences and Research Sharda University Gautam Buddha Nagar Uttar pradesh 201306 India 
 
Primary Sponsor  
Name  School of Medical Sciences and Research and Sharda Hospital Greater Noida 
Address  School of Medical Sciences and Research Sharda University Gautam Buddha Nagar Uttar pradesh 201306 India 
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 Apurva Tandon  School of Medical Sciences and Research  Block 2F Department of Anaesthesiology Sharda University, Knowledge Park III, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh – 201306 India Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 		 07006439748

apurva.tandon@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee School of Medical Sciences and Research Sharda University Greater Noida  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  Ropivacaine with Butorphanol or Dexmedetomidine  Group RB: Intrathecal 0.75% hyperbaric ropivacaine 3.5 ml + butorphanol 100 mcg (0.1 ml) Group RD: Intrathecal 0.75% hyperbaric ropivacaine 3.5 ml + dexmedetomidine 10 mcg (0.1 ml) Group RN: Intrathecal 0.75% hyperbaric ropivacaine 3.5 ml + normal saline 0.1 ml (control group) Total volume: 3.6 ml Route: Intrathecal via L3–L4 space All drugs prepared by an independent anesthesiologist (double-blind protocol) Total Duration Of interventionis 18 months 
Comparator Agent  Ropivacaine with Butorphanol or Dexmedetomidine  RB=ROPIVACAINE+BUTORPHANOL RD=ROPIVACAINE+DEXMEDETOMIDINE RN=ROPIVACAINE+NORMAL SALINE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients scheduled for infraumbilical surgery under subarachnoid block.
ASA Physical Status Grade I and II.
Age between 18 to 60 years.
Both male and female patients. 
 
ExclusionCriteria 
Details  Morbid obesity
Patient with history of adverse response to study drugs
Patient with pre-existing neurological or spinal disease, cardiovascular disease, renal, hepatic or any other systemic disease
Contraindications for spinal anaesthesia like: Raised ICP, local site infections & spinal deformities like kyphosis and scoliosis
Pregnant females
Coagulopathy or bleeding diathesis 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Time of onset of sensory and motor blockade (assessed using pinprick method and Modified Bromage scale respectively)  Every 1 minute until complete onset, then monitored intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the duration of sensory and motor blockade assessed by pin prick, Visual Analog Score (VAS) and modified Bromage scale respectively.
Changes in vitals parameters-heart rate (HR), noninvasive blood pressure (NIBP), and oxygen saturation (SPO2) intra operatively.
Requirement of first rescue analgesic in postoperative period in the first 24 hours. 		 Assessed every 1 min until onset, then every 10 min post 2 hours until full recovery
Baseline, then every 5 minutes intraoperatively and every 15 minutes post-op for 3 hours
Monitored continuously up to 24 hours post-op 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 2 
Date of First Enrollment (India)   01/08/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
This prospective, randomized, double-blind controlled trial aims to compare the effects of intrathecal butorphanol and dexmedetomidine as adjuvants to 0.75% hyperbaric ropivacaine in patients undergoing infraumbilical surgeries under spinal anaesthesia.

A total of 75 adult patients (ASA I–II) aged 18–60 years will be randomly assigned into three groups:
Group RB: Ropivacaine + Butorphanol (100 mcg)
Group RD: Ropivacaine + Dexmedetomidine (10 mcg)
Group RN: Ropivacaine + Normal Saline (control)

Primary outcome includes onset time of sensory and motor blockade. Secondary outcomes include duration of block, hemodynamic parameters, time to first rescue analgesic, and incidence of adverse effects. Patients will be monitored intraoperatively and for 24 hours postoperatively. The study will be conducted at Sharda Hospital, Greater Noida over 18 months.
 
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