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CTRI Number  CTRI/2018/05/013684 [Registered on: 04/05/2018] Trial Registered Retrospectively
Last Modified On: 03/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three drugs pethidine,butorphanol,dexmedetomidine for treatment of shivering under spinal anaesthesia 
Scientific Title of Study   Comparison of intravenous pethidine, butorphanol and dexmedetomidine for treatment of shivering under spinal anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Garima Sharma 
Designation  Secondary DNB Resident in Anaesthesiology 
Affiliation  Bhagat Phool Singh Government Medical College For Women 
Address  Operation Theatre Complex Department Of Anaesthesiology Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Operation Theatre Complex Department Of Anaesthesiology Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Haryana
Sonipat
HARYANA
131305
India 
Phone  9582891320  
Fax    
Email  garima.sharma01234@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pranav Bansal 
Designation  Professor Head Of Department Of Anaesthesia 
Affiliation  Bhagat Phool Singh Government Medical College For Women  
Address  Operation Theatre Complex Department Of Anaesthesiology Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Operation Theatre Complex Department Of Anaesthesiology Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA
131305
India 
Phone  8222007555  
Fax    
Email  pranavbansal1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Garima Sharma 
Designation  Secondary DNB Resident in Anaesthesiology 
Affiliation  Bhagat Phool Singh Government Medical College For Women 
Address  Operation Theatre Complex Department Of Anaesthesiology Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Operation Theatre Complex Department Of Anaesthesiology Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Haryana
Sonipat
HARYANA
131305
India 
Phone  9582891320  
Fax    
Email  garima.sharma01234@gmail.com  
 
Source of Monetary or Material Support  
Bhagat Phool Singh Government Medical College For Women  
 
Primary Sponsor  
Name  Bhagat Phool Singh Government Medical College For Women 
Address  Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Haryana 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Garima Sharma  Bhagat Phool Singh Government Medical College For Women  Operation Theatre Complex Department Of Anaesthesiology
Sonipat
HARYANA 
9582891320

garima.sharma01234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA I/II/III ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison Of Intravenous Pethidine, Butorphanol And Dexmedetomidine For Treatment Of Shivering Under Spinal Anaesthesia  There is no comparator agent.The three drugs will be compared amongst each other to know which one is most efficacious in abolishing shivering under spinal anaesthesia. 
Intervention  Intravenous Pethidine, Butorphanol And Dexmedetomidine For Treatment Of Shivering Under Spinal Anaesthesia  The cases will be randomly divided into 3 groups (50 patients in each group) by closed opaque envelope technique. . The study drug will be prepared by any trained staff and handed over to the investigator who will administer the drug to the patient and record the vitals. The patient as well as the investigator recording the readings will be blinded to the study drug. The nature of study drug will be revealed after all readings have been recorded for the patient under study. 1. Group P: will receive 0.5 mg/kg of inj. Pethidine intravenously. 2. Group B: will receive 0.02 mg/kg of inj. Butorphanol intravenously. 3. Group D: will receive 0.5 µg/kg Dexmedetomidine intravenously. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age 18-65 years( any gender)
2.American society of Anaesthesiologists (ASA) grade I , II &III physical status
3.Lower limb surgeries, inguinal, abdominal, urological and gynaecological procedures under spinal anaesthesia, who develop shivering during intra-operative and postoperative period (up to 2 hours) will be included in the study.
 
 
ExclusionCriteria 
Details  1.Patients with hypothyroidism or hyperthyroidism
2.Morbid Obesity (BMI> 40 kg/m2)
3.Fever (axillary temperature > 37 0 Celsius)
4.History of allergy to drugs.
5.Coagulation disorders
6.Patients with significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic diseases.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will be to compare the efficacy and response rates of pethidine, butorphanol and dexmedetomidine.  The time taken for cessation of shivering will be recorded at 1 minute interval till 5 min and thereafter upto 30 minutes.  
 
Secondary Outcome  
Outcome  TimePoints 
1.To monitor the vital parameters in all the three groups and compare them subsequently.
2.To record the incidence of recurrence in all the three groups.
3.To record and compare the incidence of adverse effects such as nausea, vomiting, sedation, etc. amongst the three groups.
 
Maximum Upto Two Hours 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   04/02/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Shivering is one of the most common complications of a central neuraxial blockade, due to impairment of the thermoregulatory control. It has been reported in 40 to 70% of patients undergoing surgery under regional anesthesia. Shivering, an oscillatory, involuntary muscular activity, is a physiological response to core hypothermia in an attempt to raise the metabolic heat production. Prolonged impairment of thermoregulatory autonomic control under anaesthesia along with the cold environment of operating rooms and cold infusion fluids, contributes to a fall in core body temperature, and hence shivering. It  increases the oxygen consumption considerably  and is uncomfortable and  distressing to the patient, anaesthesiologist, as well as to the surgeon. Shivering also increases intraocular and intracranial pressure, and may contribute to increased wound pain, delayed wound healing and delayed discharge from post-anaesthetic care unit. So, apart from being an uncomfortable experience, its deleterious effects warrant primary prevention and prompt control. This study is designed to evaluate the efficacy of intravenous Pethidine, Butorphanol, Dexmedetomidine for treatment of shivering under spinal anaesthesia. This is a randomized prospective study and will be conducted in 150 patients of both genders with age between 18-60 years, ASA I, II & III who develop shivering under spinal anaesthesia during various orthopaedic, inguinal, abdominal, gynaecological procedures. Cases will be randomly divided into 3 groups (Group P, B & D) with 50 patients in each group. Group P will receive injection pethidine 0.5 mg/kg intravenously, Group B will receive injection butorphanol  0.02 mg/kg intravenously and Group D will receive 0.5 µg/kg of injection dexmedetomidine intravenously as soon as shivering is encountered after induction of spinal anaesthesia. The time of induction of spinal anaesthesia will be noted, grading of  the shivering will be done , time of onset of shivering, time at which study drug is given and time at which shivering ceases will be noted. We will also note axillary temperature at the time of onset of shivering and and at cessation of shivering . Patients will also be observed intraoperatively for any variations in hemodyanamic parameters (heart rate, systolic and diastolic blood pressure, oxygen saturation ,respiratory rate).We will also take a note of any recurrent episode of shivering and incidence of adverse effects like hypotension, bradycardia, nausea, vomiting, dizziness, somnolence, among the groups.

 
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