| CTRI Number |
CTRI/2024/11/076187 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of a monitor called SPI versus hemodynamic parameters on use of pain medication during removal of kidney through keyhole surgery under general anesthesia - an experimental study |
|
Scientific Title of Study
|
Effect of surgical plethysmography index on perioperative opioid use in patients undergoing laparoscopic nephrectomy under general anesthesia - A randomized controlled study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharat krishna reddy kesavareddy |
| Designation |
Junior resident |
| Affiliation |
Nizams institute of medical sciences. |
| Address |
Department of Anesthesia and Intensive Care, Nizams institute of medical sciences, Panjagutta, Hyderabad.
Hyderabad,Telangana.
Hyderabad
TELANGANA
500082
India |
| Phone |
9700033346 |
| Fax |
|
| Email |
sharatkrishnareddyk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indira gurajala |
| Designation |
professor |
| Affiliation |
Nizams institute of medical sciences. |
| Address |
Department of Anesthesia and Intensive care, Nizams institute of medical sciences, Panjagutta, Hyderabad.
Hyderabad,Telangana.
Hyderabad
TELANGANA
500082
India |
| Phone |
7729932044 |
| Fax |
|
| Email |
indiradevraj@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Sharat krishna reddy kesavareddy |
| Designation |
Junior resident |
| Affiliation |
Nizams institute of medical sciences. |
| Address |
Department of Anesthesia and intensive care, Nizams institute of medical sciences, panjagutta, Hyderabad.
Hyderabad,Telangana.
Hyderabad
TELANGANA
500082
India |
| Phone |
9700033346 |
| Fax |
|
| Email |
sharatkrishnareddyk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences, panjagutta, Hyderabad, Telangana, India
pincode:500082. |
|
|
Primary Sponsor
|
| Name |
Nizams institute of medical sciences |
| Address |
Panjagutta, Hyderabad, 500082, telangana, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 K Sharat Krishna Reddy |
Nizams Institute of medical Sciences |
Speciality block operation theatre
Department of Anesthesia and intensive care, Nizams institute of medical sciences, panjagutta, hyderabad.
Hyderabad
TELANGANA |
9700033346
sharatkrishnareddyk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional 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 |
| Intervention |
opioid sparing analgesia technique through surgical plethesmography index. |
patients are divided into 2 group SPI-group and control group.
SPI- group: fentanyl group will be given 0.5mcg/kg when SPI above 50 for more than 5 minutes.
|
| Comparator Agent |
opioid sparing analgesia through SPI - guided intervention. |
In control group: injection fentanyl will be given if heart rate or blood pressure will increase more than 20% for more than 5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective laparoscopic nephrectomy,with ASA grade 1 and 2, normal renal and liver function test and hemoglobin 9gram/dl |
|
| ExclusionCriteria |
| Details |
patient refusal, emergency surgery, patients who are hemodynamically unstable, pregnant women and who has history of opiod abuse. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the amount the amount of intraoperative injection fentanyl requirement in SPI- guided group and conventional group which is based on hemodynamic response- based group. |
from time of patient induction to extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
check incidence of number of hemodynamic events such as tachycardia, unwanted somatic movements, time for extubation ( time from spontaneous breathing efforts to removal endo tracheal tube)
postoperative tramadol requirement. |
intraoperative inducation to until 24hours post operatively. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 12-01-2025 and end date provided 11-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Though systemic opioids are commonly used and provide good pain relief, there is an increase incidence postoperative nausea and vomiting, urinary retention,respiratory depression and especially in cancer patients several studies have shown that tumor recurrence and decreased disease free and overall survival rate. As it is impossible to completely do away with perioperative opioid use, emphasis has been on opioid sparing analgesia. To support this a search for newer modality has been increased which easy and inexpensive. Surgical pletysmography is new modality used to monitor nociceptive stimuli and anti-nociceptive drug effect during surgery using the pulse wave photoplethysmographic amplitude and heart rate interval derived from pulse oximetry measurements, represents the mean surgical stress level during anaesthesia. The present study is planned to evaluate the utility of SPI ( surgical plethysmograhic index ) in providing opioid sparing analgesia. This study is a randomized double blinded study which will be done in patients scheduled for laparoscopic radical nephrectomy. Conduct of study as follows, Patients are divided are into 2 groups, that is SPI- guided analgesia group injection fentanyl will be given @IV 0.5mcg/kf bolus when SPI above 50 for more than 5min. other group is that is Control group, injection fentanyl was given at standard practice based on changes in heart rate and blood pressure >20% of the base line. |