| CTRI Number |
CTRI/2024/10/074979 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Opioid sparing anesthesia in laparoscopic gall bladder surgery using Dexmedetomidine |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of dexmedetomidine for opioid-sparing anesthesia with conventional opioid-based anesthesia for elective laparoscopic cholecystectomy: a prospective 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 |
Adarsh K P |
| Designation |
Primary DNB Resident |
| Affiliation |
Aster CMI Hospital |
| Address |
Department of Anesthesia
2nd floor
Aster CMI Hospital
Sahakara Nagar
Bangalore
Bangalore KARNATAKA 560092 India |
| Phone |
09496471379 |
| Fax |
|
| Email |
kpadarsh001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arun V |
| Designation |
Head of Department |
| Affiliation |
Aster CMI Hospital |
| Address |
Department of Anesthesia
2nd floor
Aster CMI Hospital
Sahakara Nagar
Bangalore
Bangalore KARNATAKA 560092 India |
| Phone |
9496471379 |
| Fax |
|
| Email |
drarun.v@asterhospital.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Renita M Pinto |
| Designation |
Consultant |
| Affiliation |
Aster CMI Hospital |
| Address |
Department of Anesthesia
2nd floor
Aster CMI Hospital
Sahakara Nagar
Bangalore
Bangalore KARNATAKA 560092 India |
| Phone |
9496471379 |
| Fax |
|
| Email |
rensmarina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aster CMI Hospital, Sahakar Nagar, Bangalore, India 560092 |
|
|
Primary Sponsor
|
| Name |
Adarsh K P |
| Address |
Department of Anesthesia
2nd floor
Aster CMI Hospital
Sahakara Nagar
Bangalore |
| Type of Sponsor |
Other [Self] |
|
|
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 Adarsh K P |
Aster CMI Hospital |
Department of Anesthesiology Second floor
Aster CMI Hospital
Sahakara Nagar
Bangalore Bangalore KARNATAKA |
9496471379
kpadarsh001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Instituitional Ethics Committee of Aster CMI Hospital, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional opioid based Anesthesia |
Fentanyl 2mcg/kg at induction of general anesthesia Duration of intervention will be total intraoperative period |
| Comparator Agent |
Opioid sparing Anesthesia |
Dexmedetomidine loading dose 0.3mcg/kg over 10 minutes at induction followed by 0.5mcg/kg/hr infusion continued till skin closure of surgery. Duration of intervention will be total intraoperative period |
| Intervention |
Opioid sparing Anesthesia with Dexmedtomidine |
One group of patients are given Dexmedetomidine infusion with loading dose 0.3mcg/kg for 10min at induction of anaesthesia, followed by 0.5mcg/kg/hr continued till skin closure. Other group will be given Fentanyl 2mcg/kg at induction. Both groups will be premedicated with Midazolam, glycopyrolate, and general anaesthesia induced with titrated dose of Propofol and atracurium. Preincisional ultrasound guided right External oblique intercostal plane block and bilateral ultrasound guided rectus sheath block is also given. Inj Fentanyl 25mcg boluses will be given as rescue analgesic intraoperatively. Inj Paracetamol and Diclofenac is also used intraoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparoscopic cholecystectomy surgery
Patients under ASA 1 and ASA2 class
Baseline Heart rate more than 50beats per minute |
|
| ExclusionCriteria |
| Details |
Patients of ASA 3 and above
Patient refusal
Patients on betablocker drugs
Patient with history of Cardiac arrhythmia
Patients with deraged renal function
Any history of allergy to any of study drugs
Patients with history of bronchial asthma
Patients at risk of aspiration
Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total (intraoperative and postoperative) rescue Fentanyl usage for analgesia when using Dexmedetomidine infusion compared to conventional opioid based anesthesia. |
Total usage at 0hour post procedure
total usage till 24hour post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of postoperative nausea & vomiting |
post operative period till 24 hours |
| time to extubation and eye opening to call |
intraoperative |
| any complication associated with dexmedetomidine or opioid |
intraoperative & post operative period till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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 4 |
|
Date of First Enrollment (India)
|
12/10/2024 |
| 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 - 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 - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kpadarsh001@gmail.com].
- For how long will this data be available start date provided 01-10-2026 and end date provided 01-10-2031?
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
|
Laparoscopic cholecystectomy is the minimally invasive gold standard procedure for the removal of gall bladder in conditions like cholelithiasis. Unfortunately, the incidence of postoperative nausea and vomiting is as high as 55.8% which delays recovery. Perioperative opioid use is considered to be one of the reasons for it. Opioid usage is also associated with itching, respiratory depression, paralytic ileus, urinary retention, constipation, dependency, and drowsiness. Opioid-sparing anaesthesia by minimizing the perioperative opioid usage may reduce the incidence of these adverse effects and enhance recovery. In this study, Dexmedetomidine is used for opioid-sparing anaesthesia. Dexmedetomidine is a highly selective pre-synaptic alpha-2 receptor agonist having sedative, anxiolytic, hypnotic, analgesic and sympatholytic properties. Various studies have shown the analgesic efficacy of dexmedetomidine and its hemodynamic stability in varying doses and in conjunction with other opioid sparing techniques. Studies have established the effect of dexmedetomidine in reducing post-operative nausea and vomiting compared to opoid based anaesthesia. This study compares opioid sparing effect of dexmedetomidine in conjunction with ultrasound-guided right external oblique intercostal nerve block and bilateral rectus sheath block for elective laparoscopic cholecystectomy against conventional opioid based technique. Objective of the study is to measure total rescue opioid requirement in intraoperatiev and post operative period in using dexmetomidine infusion compared to conventional opioid based anaesthesia. Incidence of any post operative nausea vomiting, and any complication is also compared. Time to extubation and post operative pain scores are also compared This is a prospective open label randomised control study conducted in Aster CMI Hospital, Bangalore, in 78 patients between 18 to 65years undergoing elective Laparoscopic Cholecystectomy surgery belonging to ASA 1 and ASA2. Any patients having contraindication to study drugs is excluded from the study. One group of patients are given Dexmedetomidine infusion with loading dose 0.3mcg/kg for 10min at induction of anaesthesia, followed by 0.5mcg/kg/hr. Other group will be given Fentanyl 2mcg/kg at induction. Both groups will be premedicated with Midazolam, glycopyrolate, and general anaesthesia induced with titrated dose of Propofol and atracurium. Preincisional ultrasound guided right External oblique intercostal plane block and bilateral ultrasound guided rectus sheath block is also given. Inj Fentanyl 25mcg boluses will be given as rescue analgesic intraoperatively. Inj Paracetamol and Diclofenac is also used intraoperatively. Perioperative vitals, total Fentanyl usage, post operative pain scores and any incidence of complication will be measured, analysed and compared |