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CTRI Number  CTRI/2025/02/080377 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 11/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of dexmedetomidine and clonidine with 0.5% hyperbaric levobupivacaine in spinal anaesthesia 
Scientific Title of Study   A comparative study of dexmedetomidine versus clonidine as adjuvant to intrathecal 0.5 percent hyperbaric levobupivacaine in infraumbilical surgeries 
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 R Sanjna 
Designation  PG Junior Resident 
Affiliation  ACS Medical College and Hospital 
Address  Department of Anaesthesiology, ACS Medical College and Hospital, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  9000786543  
Fax    
Email  sanjna1901@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Selvamani 
Designation  Professor 
Affiliation  ACS Medical College and Hospital 
Address  Department of Anaesthesiology, ACS Medical College and Hospital, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  9444357942  
Fax    
Email  dr.selvamani1957@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S Selvamani 
Designation  Professor 
Affiliation  ACS Medical College and Hospital 
Address  Department of Anaesthesiology, ACS Medical College and Hospital, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  9444357942  
Fax    
Email  dr.selvamani1957@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, ACS medical college and hospital, velappanchavadi, chennai 600077 
 
Primary Sponsor  
Name  Department of Anaesthesiology ACS Medical College and Hospital 
Address  Department of Anaesthesiology, ACS Medical College and Hospital, velappanchavadi, Chennai 600077 
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 R Sanjna  ACS medical college and hospital, Velappanchavadi, chennai 600077  Department of anaesthesiology, basement surgery OT, Orthopedics OT, Obstetrics and gynaecology OT
Thiruvallur
TAMIL NADU 		 09000786543

sanjna1901@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. M.G.R Educational and Research Institute(deemed to be university), Velappanchavadi, Chennai 600077, 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, (2) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  30 mcg (0.2ml) of clonidine as adjuvant to intrathecal 3ml (15mg) of 0.5% hyperbaric levobupivacaine  to determine and compare the effects, safety and efficacy of 30mcg clonidine vs 5 mcg dexmedetomidine as adjuvant to intrathecal 0.5% hyperbaric levobupivacaine in infraumbilical surgeries, route - intrathecal (spinal anaesthesia), frequency - spinal anaesthesia given once before the start of procedure, duration of intervention - study drugs are given as spinal injection and observations will be made from the time of spinal injection till the end of surgery and postoperatively until effect of drugs wear off 
Comparator Agent  5 mcg (diluted to 2ml) dexmedetomidine as adjuvant to intrathecal 3ml (15mg) of 0.5% hyperbaric levobupivacaine   to determine and compare the effects, safety and efficacy of 5mcg dexmedetomidine vs 30mcg clonidine as adjuvant to intrathecal 0.5% hyperbaric levobupivacaine in infraumbilical surgeries. route - intrathecal (spinal anaesthesia), frequency - spinal anaesthesia given once before the start of procedure, duration of intervention - study drugs are given as spinal injection and observations will be made from the time of spinal injection till the end of surgery and postoperatively until effect of drugs wear off  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients of American society of Anaesthesiologists physical status I and II
2. Age 18yrs to 80 yrs
3. Patients undergoing Infraumbilical Surgeries
4. Patients who have given informed written consent
 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Patients of American society of Anaesthesiologists physical status III and IV.
3. Coagulopathies.
4. Infection at site of lumbar puncture.
5. Allergy to local anaesthetic drugs, dexmedetomidine & clonidine.
6. H/o seizures/ neurological deficit.
7. Lack of informed written consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To determine the time to onset and duration of sensory and motor block
2.To determine the quality of intraoperative anaesthesia

 		 1.Time to onset of sensory, motor block, from spinal injection-at level of umbilicus-assessed at baseline,1min,3min,5min,7min,10min,15min. Duration of sensory and motor blockade- assessed at baseline, 30min,60min,90min,every 30min during and after surgery.
2. quality of intraoperative anaesthesia-assessed at baseline,1min,3min,5min,10min and 10min thereafter until end of surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the time taken for first rescue analgesia
2.To determine adverse effects

 		 1.time taken for first rescue analgesia-assessed postoperatively at 15min,30min,45min,60min & every 30min thereafter
2.Patient is monitored for adverse effects(headache, nausea, confusion, hypotension, bradycardia, etc), hemodynamic parameters at baseline,1min,3min,5min,15min,30min,45min,1hr & every 30 min postoperatively & will be managed meticulously 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   25/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjna1901@gmail.com].

  6. For how long will this data be available start date provided 01-03-2025 and end date provided 01-03-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   AIM: The aim of this study is to compare the effects, safety and efficacy of 5 mcg of dexmedetomidine with 30 mcg of clonidine when added to intrathecal 0.5% hyperbaric levobupivacaine in infraumblical surgeries. OBJECTIVES:
(a) To determine the time to onset and duration of sensory and motor block
(b) To determine the quality of intraoperative anaesthesia.
(c) To determine the time taken for first rescue analgesia. 
(d) To determine adverse effects.
(e) To determine changes in hemodynamic parameters intraoperatively and postoperatively
Method:
100 patients of American Society of Anaesthesiologists – physical status I and II will be randomly divided into groups C and D. 
GROUP C: Patients in this group(n=50) will receive intrathecal 15 mg (3 ml) of 0.5% Hyperbaric Levobupivacaine with 30 mcg (0.2ml) of Inj. Clonidine. 
GROUP D: Patients in this group(n=50) will receive intrathecal 15 mg (3 ml) of 0.5% Hyperbaric Levobupivacaine with 5 mcg (diluted to 0.2ml) of Inj. Dexmedetomidine.
Patients shall undergo randomization by odd numbers and even numbers.
For odd numbers, Clonidine shall be the adjuvant to 0.5% hyperbaric levobupivacaine (group C). For even numbers, Dexmedetomidine shall be the adjuvant to 0.5% hyperbaric levobupivacaine(group D).
ANAESTHETIC PROCEDURE :
Anaesthesia machine is checked before starting the procedure.
Availability of working laryngoscope, endotracheal tubes of various sizes, other airway equipments will be ensured.
Availability of essential and emergency drugs will be ensured.
Following the arrival of patient in the pre anesthetic room, intravenous access will be established with appropriate IV Cannula and patient will be preloaded with crystalloids(15ml/kg) before giving sub arachnoid block.
Standard ASA monitoring will be used throughout the procedure with the help of a multi paramonitor (Electrocardiograpy(ECG), pulse oximetry(SpO2), temperature, NonInvasive Blood Pressure (NIBP).
Baseline vitals (HR, BP, RR, SPO2) will be recorded.
Patients will be placed in sitting or lateral position. Under strict aseptic precautions, lumbar puncture will be performed in L2/L3 or L3/L4 interspace using 25 G Quincke - Babcock spinal needle following local infiltration with 2 ml of Inj. Lignocaine 2%. 
Correct placement of the spinal needle is identified by clear, free flow of the cerebrospinal fluid (CSF). 
The study drug will then be injected into the subarachnoid space according to group allocation as 3 ml of 0.5% hyperbaric bupivacaine (15 mg) with 0.2 ml (30 mcg) of Inj. Clonidine in group C and 3 ml of 0.5% hyperbaric levobupivacaine (15 mg) with 5 mcg (diluted to 0.2 ml) of Inj. Dexmedetomidine in group D.
After injecting the drug, patient is placed in supine position.
Sensory block : Sensory blockade achieved will be tested by the loss of pain & temperature sensation.
The time to reach T10 level will be recorded.
Time to Peak Sensory block with the level attained will be recorded.
Time to regress upto S1 dermatomal level will be recorded.
Duration of sensory block will be documented.
Motor block : Time to achieve complete motor block (Bromage 3) and Time to regress (to Bromage 0) will be recorded.
Motor blockade is assessed using modified Bromage scale:
Bromage 0 – able to move hip, knee and ankle
Bromage 1 – able to move knee and ankle
Bromage 2 – able to move ankle only
Bromage 3 – unable to move
INTRAOPERATIVE SEDATION: Sedation is assessed by Ramsay sedation scale: 
 1 - anxious and agitated/restless/both 
 2 - cooperative, oriented and calm
 3 - responsive to commands only
 4 - exhibiting brisk response to light glabellar tap or loud auditory stimulus
 5 - exhibiting sluggish response to light glabellar tap or loud auditory stimulus
 6 - unresponsive
Quality of intaoperative anaesthesia will be noted as excellent or good or poor
Quality of analgesia will be assessed by VAS: 0 – no pain 1–3 – mild pain 4–6 – moderate pain 7–10 – severe pain.
Time of first rescue analgesic will be noted
Adverse effects will be watched for, monitored and managed meticulously
Hemodynamic parameters - blood pressure, Heart rate, respiratory rate, oxygen saturation in pulse oximetry and mean arterial pressure will be noted at base line and specific intervals intraoperatively and postoperatively 

 
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