| CTRI Number |
CTRI/2020/12/030091 [Registered on: 29/12/2020] Trial Registered Prospectively |
| Last Modified On: |
12/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Postoperative Analgesia in patients of Anterior Cervical Discectomy and Fusion (ACDF) Surgery |
|
Scientific Title of Study
|
Comparison of Ketamine Versus Fentanyl Infusion for Postoperative Analgesia in patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tarun Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
Department of Anesthesiology
Geetanjali Medical College and Hospital
Udaipur
Udaipur
RAJASTHAN
313002
India |
| Phone |
9983688263 |
| Fax |
|
| Email |
tarun_s80@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelesh Bhatnagar |
| Designation |
Associate Professor |
| Affiliation |
Geetanjali Medical College andHospital |
| Address |
Department of Anesthesiology
Geetanjali Medical College and Hospital
Udaipur
Udaipur
RAJASTHAN
313002
India |
| Phone |
8890663427 |
| Fax |
|
| Email |
drneelesh1106@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelesh Bhatnagar |
| Designation |
Associate Professor |
| Affiliation |
Geetanjali Medical College andHospital |
| Address |
Department of Anesthesiology
Geetanjali Medical College and Hospital
Udaipur
Udaipur
RAJASTHAN
313002
India |
| Phone |
08890663427 |
| Fax |
|
| Email |
drneelesh1106@gmail.com |
|
|
Source of Monetary or Material Support
|
| Geetanjali Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Tarun Singh |
| Address |
Department of Anesthesiology
Geetanjali Medical College and Hospital
Udaipur
Rajasthan 313002 |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunanda Gupta |
Geetanjali Medical College and Hospital |
Department of Anesthesiology
Hiranmagri Extension, Manwakhera NH-8 Bypass, Near Eklingpura Chouraha Udaipur-313002
Udaipur
RAJASTHAN |
02942500000
sunandagupta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Fentanyl for post operative analgesia in ACDF surgery |
Drug to be started at 0.5 mcg/kg/hr intraoperatively and then continued at 0.25 mcg/kg/hr post operatively |
| Intervention |
Injection Ketamine for post operative analgesia in ACDF surgery |
Drug to be started at 0.25 mg/kg/hr intraoperatively and then continued at 0.125 mg/kg/hr post operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA physical status I and II, aged 18 to 65 years with of BMI <30 with cervical disc prolapse scheduled for single or multiple level anterior cervical discectomy and fusion. |
|
| ExclusionCriteria |
| Details |
Patients who have traumatic cervical spine injury, underwent prior cervical disc surgery, prior respiratory compromise, preoperative opioid or steroids use, hypersensitivity to the subject drugs and patients whose mental status will affect the completion of the QoR-15 questionnaire. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of ketamine versus fentanyl infusion for postoperative analgesia in patients undergoing ACDF in terms of:
a.Visual Analog Score
b. Time to first rescue analgesic
c. Number and total dose of rescue analgesic |
Intraoperative and 24 hours post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare:
a.Degree of overall satisfaction using quality of recovery score (QoR score).
b.Hemodynamic variables between the two groups in intra and postoperative period.
c.Incidence of postoperative complications like as nausea, vomiting, hypotension, dry mouth, allergic reaction, respiratory depression, urinary retention and dysphoria.
d.Postoperative sedation (Ramsay Sedation Score)
|
Intraoperative and 24 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "83"
Final Enrollment numbers achieved (India)="83" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2020 |
| Date of Study Completion (India) |
11/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison
of Ketamine Versus Fentanyl Infusion for Postoperative Analgesia in patients
undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgery as a topic for thesis for award of the degree of Doctor of Medicine (M.D. Anesthesiology) being undertaken as a prospective randomized controlled double blind study comprising of all
the patients admitted to GMCH for anterior cervical discectomy and fusion surgery. A minimum of 82 patients will be randomized into two groups of 41 each
by computer generated random number using Microsoft Excel program. |