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
|
|
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. |