CTRI Number |
CTRI/2013/06/003755 [Registered on: 14/06/2013] Trial Registered Prospectively |
Last Modified On: |
19/04/2013 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare the effect of Fentanyl and Dexmedetomidine when added to bupivacaine in Spinal Anaesthesia |
Scientific Title of Study
|
EFFECT OF ADDING DEXMEDETOMIDINE VERSUS FENTANYL TO INTRATHECAL BUPIVACAINE ON SPINAL BLOCK CHARACTERISTICS IN GYNAECOLOGICAL PROCEDURES: A DOUBLE BLIND CONTROLLED STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1138-3349 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr NIKHIL NANDAN |
Designation |
JUNIOR RESIDENT |
Affiliation |
Govt Medical College, Trivandrum |
Address |
DR.NIKHIL NANDAN
JUNIOR RESIDENT
DEPARTMENT OF ANAESTHESIOLOGY
GOVT. MEDICAL COLLEGE,
TRIVANDRUM
Thiruvananthapuram KERALA 695011 India |
Phone |
|
Fax |
|
Email |
nikhilnandan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr LINETTE J MORRIS |
Designation |
PROFESSOR |
Affiliation |
|
Address |
DR. LINETTE J. MORRIS
PROFESSOR OF ANAESTHESIA
DEPARTMENT OF ANAESTHESIOLOGY
GOVT. MEDICAL COLLEGE, TRIVANDRUM
Thiruvananthapuram KERALA 695011 India |
Phone |
|
Fax |
|
Email |
linettemorris5@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr NIKHIL NANDAN |
Designation |
JUNIOR RESIDENT |
Affiliation |
Govt Medical College, Trivandrum |
Address |
DR.NIKHIL NANDAN
JUNIOR RESIDENT
DEPARTMENT OF ANAESTHESIOLOGY
GOVT. MEDICAL COLLEGE,
TRIVANDRUM
Thiruvananthapuram KERALA 695011 India |
Phone |
|
Fax |
|
Email |
nikhilnandan@gmail.com |
|
Source of Monetary or Material Support
|
Govt Medical College Trivandrum |
|
Primary Sponsor
|
Name |
Govt Medical College Trivandrum |
Address |
GOVERNMENT MEDICAL COLLEGE
MEDICAL COLLEGE P.O
PIN - 695011 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Nikhil Nandan |
Junior Resident
Department of Anaesthesiology
Govt. Medical College
Trivandrum |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Nikhil Nandan |
obstetric and gynaecology OT including pre and postoperative care room |
Department of Anaesthesiology
Sree Avittam Thirunal Hospital
Govt. Medical College Trivandrum Thiruvananthapuram KERALA |
9895415212
nikhilnandan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Human Ethics Commitee Medical College Trivandrum |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Elective Gynaecological Surgeries, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Bupivacaine with Dexmedetomidine |
Dose -2cc 0.5%(Heavy) bupivacaine (10mg ) + 5µg Dexmedetomidine in 0.5 cc preservative free solution
Frequency -single shot
Route -Intrathecal |
Comparator Agent |
Bupivacaine with Fentanyl |
Dose - 2cc 0.5%(Heavy) bupivacaine (10mg ) + 25µg fentanyl in 0.5 cc of preservative free solution.
Frequency - single shot
Route-Intrathecal |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Female |
Details |
ASA I / II / III of ASA physical status classification.
Height 155 to 175 cm
|
|
ExclusionCriteria |
Details |
Patients having drug allergy to local anaesthetics.
Those with anatomical abnormalities of the spine, peripheral neuropathy, bleeding disorders or anticoagulation therapy.
Patients with serious systemic illness, psychiatric illness, mental retardation.
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Duration of analgesia in terms of time for onset of mild pain postoperatively visual analogue scale 4 and above or patient request for analgesia |
Visual analogue scale assessed every 15 minutes till score reaches 4 and above or till the patient requests analgesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time for onset of adequate level of analgesia ( T10 level assessed by bilateral pin prick ) |
Intraoperative |
Peak sensory level reached |
Intraoperative |
Time taken for motor block to recede to Bromage |
Intraoperative and Postoperative |
Sedation produced by the two groups |
Intraoperative every 15 minutes |
Haemodynamic profile of the two groups |
every minute for the first 20 minutes and every two-minute for the next 20 minutes and every five minutes till the end of surgery and then every 10-15 minutes for three hours post operatively |
Need of additional analgesic |
Intraoperative |
• Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups |
Intraoperative and Postoperative |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/07/2013 |
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) |
Not Yet Recruiting |
Publication Details
|
Non yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Dexmeditomedine is an α-2 adreno receptor agonist, which is approved as an intravenous sedative and analgesic drug. It is a useful adjuvant in regional anesthesia. Kanazi et al, found that 5μg Dexmeditomedine and 50μg clonidine are equipotent intrathecally when added to Bupivacaine in patients undergoing major surgeries in the abdomen and lower extremities. Dexmeditomedine given intrathecally along with Bupivacaine produce significantly longer duration of sensory and motor block than Bupivacaine alone without serious side effects. It maintains patient arousability and respiratory function. Dexmeditomedine has a role in the field of critical care and it also facilitates easy weaning from mechanical ventilation. Fentanyl is a potent, synthetic narcotic analgesic with a rapid onset and short duration of action. It is a strong agonist at the μ-opioid receptors. Historically it has been used to treat breakthrough pain and is commonly used in pre-procedures as a pain reliever as well as an anaesthetic in combination with a benzodiazepine. Fentanyl is approximately 100 times more potent than morphine, with 100 micrograms of fentanyl approximately equivalent to 10 mg of morphine and 75 mg of pethidine (meperidine) in analgesic activity.It has an LD50 of 3.1 milligrams per kilogram in rats, and an LD50 of 0.03 milligrams per kilogram in monkeys. Gynaecological procedures including vaginal hysterectomy, recanalization, ovarian cystectomy are often done under regional anesthesia. Surgery on the uterus and other genital organs performed under epidural or spinal block is often accompanied by visceral pain, nausea and vomiting. Fentanyl in various doses (10, 20, 30, 40 μg) when added to spinal Bupivacaine increase the duration of analgesia and reduce intraoperative nausea and vomiting. Dexmedetomidine is an α2- adrenoreceptor agonist that is approved as an intravenous sedative and coanalgesic drug. Its use is often associated a decrease in heart rate and blood pressure. Intrathecal and epidural characteristics of Dexmedetomidine were studied in animals. Most of the clinical studies about intrathecal α2 adrenoreceptor agonist are related to clonidine. There is little in the literature about the use of intrathecal Dexmedetomidine with local anaesthesia in humans. Kanazi et al.found that 3 μg Dexmedetomidine and 30 μg clonidine are equipotent intrathecally when added to bupivacaine in patients undergoing urology procedures. The same author found that Dexmedetomidine and Clonidine produced significant short onset of sensory and motor block as well as significantly longer duration of sensory and motor block than Bupivacaine alone without serious side effects. The aim of this study is to compare the effect of Dexmedetomidine 5μg versus fentanyl 25 μg on intraoperative analgesia and the duration of sensory motor block when added to 10 mg intrathecal plain bupvacaine. |