| CTRI Number |
CTRI/2021/07/034882 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare The Efficacy Of Dexmedetomidine V/S Fentanyl In General Anesthesia Technique In Laparoscopic Surgeries |
|
Scientific Title of Study
|
To Compare The Efficacy Of Dexmedetomidine V/S Fentanyl Based General Anesthesia Technique In Attenuating Neuroendocrine And Haemodynamic Stress Response In Laparoscopic Surgeries |
| Trial Acronym |
Lap Dex Fent |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHILPA SARANG KORE |
| Designation |
Assistant Professor |
| Affiliation |
Dr DY Patil Medical College And Research Centre |
| Address |
Department of Anaesthesiology Dr DY Patil Medical College
Pimpri
Pune
MAHARASHTRA
411018
India
Department of anesthesia
Dr DY Patil Medical College and Research Centre
Pune
MAHARASHTRA
411019
India |
| Phone |
09767002436 |
| Fax |
|
| Email |
shilpasale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHILPA SARANG KORE |
| Designation |
Assistant Professor |
| Affiliation |
Dr DY Patil Medical College And Research Centre |
| Address |
Department of Anaesthesiology Dr DY Patil Medical College
Pimpri
Pune
MAHARASHTRA
411018
India
Department of anesthesia
Dr DY Patil Medical College and Research Centre
MAHARASHTRA
411019
India |
| Phone |
09767002436 |
| Fax |
|
| Email |
shilpasale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHILPA SARANG KORE |
| Designation |
Assistant Professor |
| Affiliation |
Dr DY Patil Medical College And Research Centre |
| Address |
Department of Anaesthesiology Dr DY Patil Medical College
Pimpri
Pune
MAHARASHTRA
411018
India
Department of anesthesia
Dr DY Patil Medical College and Research Centre
MAHARASHTRA
411019
India |
| Phone |
09767002436 |
| Fax |
|
| Email |
shilpasale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy, DY Patil Medical college, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Shilpa Sarang Kore |
| Address |
Assistant professor, Dr DY Patil Medical College, Pimpri, Pune |
| 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 Shilpa Sarang Sale |
DY Patil Medical College and research centre |
Dr. D. Y. Patil Medical College, Hospital & Research Centre, Sant Tukaram Nagar, Pimpri, Pune 411018 Maharashtra, India.
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
09767002436
shilpasale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics sub committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine (100micrograms diluted in 49 cc 0.9% NS) loading dose at 1mcg/kg over 10 mins followed by infusion at 0.2 mcg/kg/hour until the end of surgery |
| Comparator Agent |
Fentanyl |
100micrograms diluted in 48 cc 0.9% NS) loading dose at 1mcg/kg over 10 mins followed by infusion at 0.2 mcg/kg/hour until the end of surgery |
| Intervention |
General Anaesthesia |
INDUCTION OF GENERAL ANAESTHESIA
Before induction patients in group D will receive I.V Dexmedetomidine at 1mcg/kg as loading dose over 10 min and then continuous infusion at the rate of 0.2 mcg/kg throughout the surgery. In group F will receive Fentanyl 1mcg/kg as loading dose over 10min and then continuous infusion at the rate of 0.2 mcg/kg throughout surgery. A balanced general anesthesia technique will be adopted for all patients,
Premedication will be done with Inj. Glycopyrrolate 0.2mg, Inj midazolam 1mg, will be given intravenously.
All patients will be pre-oxygenated with 100% of O2 by mask for 3 minutes.
Induction with Inj. Propofol (2mg/kg) given slowly till the patient is induced and the vital parameters will be recorded again. The intubation will be facilitated by intravenous administration of injection succinyl choline 100mg. The choice of muscle relaxant will be inj Vecuronium. Oxygen and Nitrous oxide will be continued (50% each) along with isoflurane (0.8-1.5%). The vital parameters will be recorded again.
Laryngoscopy and tracheal intubation will be attempted by the same trained and qualified anesthesiologist followed by recording of the vital parameters. Once the tracheal intubation has been achieved, the surgery will be allowed to proceed after fixing the endotracheal tube and confirming the bilateral air entry and giving positive pressure ventilation. Pneumoperitoneum created by intra peritoneal CO2 insufflation @ 2Ltrs/min and intra-abdominal pressure (IAP) maintained between 10-14mmHg throughout surgery. Monitoring of parameters, i.e., heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) will be noted at, before the start of infusion, after induction, after intubation and after pneumoperitoneum, 5 mins after pneumoperitoneum, thereafter every 20 mins till the end of surgery and extubation. At the end of surgery neuromuscular blockade will be reversed with Inj Neostigmine 0.05mg/kg and Inj Glycopyrrolate 0.008mg/kg and after meeting extubation criteria, will extubate the patients and transfer the patient to recovery and monitor for hemodynamics, and post-operative side effects.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective laparoscopic surgeries
patients undergoing elective laparoscopic surgeries under general anaesthesia
haemodynamically stable patients with routine investigations within normal limits without any other comorbidities
availability of informed written consent |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with ASA III or more
Age below 18 years and above 60 years
patients posted for emergency surgeries
patients who are on drugs that can influence hemodynamic and autonomic functions.
patients with predictably difficult airway or difficult intubation
history of cardiac disease and neurologic disease
pregnancy and breast feeding women |
|
|
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 dexmedetomidine v/s fentanyl based general anaesthesia technique in attenuating neuroendocrine and hemodynamic stress response in laparoscopic surgeries. |
Every 5 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effects of dexmedetomidine and fentanyl on hemodynamic parameters during perioperative period |
Every five minutes post intubation |
| to investigate the effects of dexmedetomidine and fentanyl on modulation of neuroendocrine stress response during elective laparoscopic surgeries |
half an hour post intubation, 2 hours post extubation |
| Observe side effects of dexmedetomidine and fentanyl and their management |
Anytime after administrating drugs until 24 hours post op |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/07/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil
|
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
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 - Proposals should be directed to [shilpasale@gmail.com].
- For how long will this data be available start date provided 01-01-2022 and end date provided 31-12-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Before induction patients will receive their respective drugs, drug preparation will be done by an anaesthesiologist who will not be involved in administration of anesthesia and patient care. The monitoring will be done by another doctor who is not involved in drug administration, data collection will be done by someone not involved in drug administration. The patients will receive their respective drugs as a loading dose over 10 mins, followed by at a rate of 0.2 mcg/kg/ hour throughout the surgery. Balanced general anaesthesia will be adopted for all patients. Once intubated, and pneumoperitoneum is attained parameters are monitored at serial intervals and blood samples are analyzed by glucometer for blood glucose level. Various adverse effects will be observed. |