| CTRI Number |
CTRI/2024/06/069025 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare the effect of Intraoperative infusion of Remifentanil versus Fentanyl on pain management post operatively in patients undergoing spine surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of effect of Intraoperative infusion of Remifentanil versus fentanyl on post-op pain management in patients undergoing elective spine surgery under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhwani Sheth |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
08460593342 |
| Fax |
|
| Email |
dhwanisheth98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeta Chaudhary Verma |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788378382 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeta Chaudhary Verma |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788378382 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawani Meghe, Wardha, 442001 |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India
442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Dhwani Sheth |
Jawaharlal Nehru Medical College |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
08460593342
dhwanisheth98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Fentanyl is a highly potent synthetic piperidine opioid primarily used as an analgesic. The most dangerous adverse effect of fentanyl is respiratory depression. We will be giving 0.1 mcg/kg/hour infusion intraoperatively till the end of surgery |
| Intervention |
Remifentanyl |
Remifentanyl is an ultra-short acting opioid that facilitates hemodynamic and neurologic management. Owing to its short half life it is preferred as an infusion. Postoperatively remifentanil was associated with faster recovery, more frequent postoperative analgesic requirements and fewer respiratory events requiring naloxone. We will be giving 0.2mcg/kg/min infusion intraoperatively till the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving informed consent
No history of substance abuse
BMI more than thirty-five
ASA grade one, two, three
Patients posted for spine surgery
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
BMI more than thirty-five
ASA grade four and above
Patients who received opioids within two days prior to surgery
Known hypersensitivity to opioids
Pregnant females |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Remifentanyl is better alternative to Fentanyl in pain management in spine surgery patients |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of hemodynamic parameters during intraoperative & postoperative period
2. Assessment of postoperative opioid consumption
3. evaluation of postoperative nausea & vomiting
4. compare total amount of rescue analgesics (IV Tramadol) used during 24 hour postoperative period
5. study side effects & complications during postoperative period |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 2 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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
|
Remifentanyl is better alternative to Fentanyl in pain management in spine surgery patients. It is a randomized double blinded study for a 2 year period for patients posted for spine surgery who will be receiving intraoperative infusion of either Remifentanyl or Fentanyl. The assessment of postoperative nausea and vomiting, postoperative opioid consumption along with the comparison of hemodynamic parameters during intraoperative and postoperative period will be done. |