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CTRI Number  CTRI/2024/07/070219 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
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   Effects of intravenous dexmedetomidine on spinal anesthesia in surgeries below umbilicus.  
Scientific Title of Study   Effects of intravenous infusion of dexmedetomidine on spinal anesthesia with 0.5% hyperbaric levobupivacaine in infraumbilical surgeries. A prospective double-blind randomised controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreenidhi Dhumwad 
Designation  Junior resident  
Affiliation  SDM College of Medical Sciences and Hospital, Dharwad.  
Address  Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  7899134276  
Fax    
Email  shreenidhidhumwad1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rachana Kori 
Designation  Senior Resident  
Affiliation  SDM College of Medical Sciences and Hospital, Dharwad.  
Address  Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  8277439222  
Fax    
Email  Rachana.kori@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rachana Kori 
Designation  Senior Resident  
Affiliation  SDM College of Medical Sciences and Hospital, Dharwad.  
Address  Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  8277439222  
Fax    
Email  Rachana.kori@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Medical Sciences and Hospital, Dharwad. 
 
Primary Sponsor  
Name  SDM college of medical sciences an d hospital  
Address  SDM college of medical sciences and hospital , Sattur , Dharwad, Karnataka, India. 580009 
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 Shreenidhi Dhumwad  SDM college of Medical Sciences and Hospital  OT number 1 to 8, Main OT complex, SDM Hospital, Sattur, Dharwad.
Dharwad
KARNATAKA 
07899134276

shreenidhidhumwad1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC - SDM College of Medical Sciences and Hospital.  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  Group D   Group D received Dexmedetomidine infusion at 0.5microgram/kg/hour from 5 minutes before administering SAB till the end of surgery. 
Comparator Agent  Group S  Group S received normal saline.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients scheduled for infra umbilical surgeries of less than 2 hour duration.
ASA physical status 1 and 2.
Basal metabolic index of less than 30 kg per sq meters.  
 
ExclusionCriteria 
Details  Patients with coagulopathy or hypovolemia.
Pregnant patients.
Obese patients. (BMI more than 30 kg per sq meters)
Height of the patients more than 180 cm or less than 150 cm.
Patients with significant cardiovascular system, pulmonary, hepatic, renal, neurological or psychological diseases.
Recent use of any analgesics, sedative drugs or antidepressants.
History of alcohol abuse.
Any contraindications to SAB.
 
 
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 
To compare the onset and duration of the analgesia with or without dexmedetomidine infusion in SAB by 0.5% hyperbaric levobupivacaine.  The sensory blockade is assessed every minute until the T10-T12 dermatome level is achieved, then 5,10,15,20 and 30 minutes after intrathecal injection of Bupivacaine, then every 15 minutes thereafter. 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on motor blockade.  The duration of motor blockade (DMB) will be assessed at 15 min intervals after the immediate end of surgery. 
Incidence of sedation.   The level of sedation is evaluated intra- operatively and post-operatively every 15 min using Ramsey Level of Sedation Scale (RSS). 
Incidence of hemodynamic changes.  Hemodynamic changes evaluated by NIBP, HR monitoring intra-operatively and post operatively every 5 minutes.  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/07/2024 
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 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  
After obtaining permission from the institutional ethical committee and informed consent from the patient, patients will be included in this prospective randomized double blind comparative study.
Pre anesthetic examination and preparation: Patients will undergo routine pre anesthetic examination before considering surgery. We will enroll patients who fulfill inclusion criteria for the study. We will obtain a written informed consent from the patient. Patients will be kept nil-per-oral for 8 hours and pre-medicated with oral pantoprazole 40 mg on the previous night of surgery.
On the day of surgery, we will re-assess the patients in the preoperative room. Secure intravenous access with a wide bore 18G cannula and record the baseline vital data like Pulse rate (PR), Blood pressure (BP) and SpO2.
METHODOLOGY
After shifting to the operation theater (OT), IV drip set is connected, all American society of Anaesthesiologists (ASA) monitors will be attached and initial readings are noted. Patient will receive IV Ringer’s lactate solution, according to the weight.
A syringe of 50 cc will be prepared with either normal saline or dexmedetomidine diluted with 2 μg/ml. Patients allocated to group D received through the intravenous infusion pump, a dose of 0.5 μg/kg/hr till the end of surgery. Group S received the same calculated volume of normal saline.
Five minutes before administering SAB Dexmedetomidine infusion will be started. In the lateral position and under aseptic precautions, local skin infiltration using 2 ml of 2% lignocaine at L2-L3 or L3 -L4 space, in the midline. Using 25 G Quinke’s spinal needle SAB will be done and 15mg (3ml) of 0.5% hyperbaric Levobupivacaine will be injected & the patient will be brought to the supine position.
In case of failure with the two above-mentioned attempts; the procedure will be abandoned, general anesthesia administered and those patients will be excluded from the study.
Another investigator, who will not know which infusion drug is administered to the respective groups will assess the sensory level at the midline for each patient by a pin prick test using a blunt 23-gauge needle.
The times required to reach loss of sensation at T10-T12 dermatome (onset time) and the maximum dermatome level, at which sensation is lost, will be recorded.
    
 The sensory blockade is assessed every minute until the T10-T12
     dermatome level is achieved, then 5,10,15,20 and 30 minutes after intrathecal injection of Bupivacaine, then every 15 minutes thereafter.
The duration of sensory blockade will be assessed by time for two- dermatome sensory regression (TDR) and recovery of L2 dermatome sensation (duration of spinal anesthesia, DSA). The duration of motor blockade (DMB) will be assessed at 15 min intervals after the immediate end of surgery, by determining the time required to recover knee flexion 10 cm above the surface of the bed.(Bromage 3)
Vital signs will be measured every 2.5 minutes for the first 10 minutes after Dexmedetomidine infusion of the study drug and then every 5 minutes during surgery.
The level of sedation is evaluated intra- operatively and post-operatively every 15 min using Ramsey Level of Sedation Scale (RSS):
1. Patient anxious, agitated, or restless.
2. Patient cooperative, oriented, and tranquil alert.
3. Patient responds to commands.
4. Asleep, but with brisk response to light glabellar tap or loud auditory stimulus.
5. Asleep, sluggish response to light glabellar tap or loud auditory stimulus. 6. Asleep, no response.
All sedation scores were recorded considering the time of start infusion as time zero.
Hypotension will be defined as mean arterial pressure MAP<60 mm hg or less than 80% of baseline, and is treated with incremental doses of intravenous ephedrine 5-10mg. Heart rate < 50 beats/min will be as treatment needed Bradycardia and treated with 0.6 mg intravenous atropine.
Hypotension, treatment-needed bradycardia, oxygen desaturation and excessive sedation (Ramsey scale < 3) will be recorded.
 
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