| CTRI Number |
CTRI/2024/12/078585 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| 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
|
Comparison of time to recovery by sugammadex vs neostigmine for vecuronium reversal in patients undergoing laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparison study of time to recovery by sugammadex vs neostigmine for vecuronium reversal in patients undergoing laparoscopic cholecystectomy A Randomized controlled trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Praveen kumar |
| Designation |
post graduate first year. |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam
Pondicherry
India
Aarupadai veedu medical College and hospital, kirumampakam,cuddalore main road, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8903636680 |
| Fax |
|
| Email |
praveenkumardpi97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gauthama buddha |
| Designation |
Assistant professor |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam
Pondicherry
India
Aarupadai veedu medical College and hospital, kirumampakam,cuddalore main road, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9786610917 |
| Fax |
|
| Email |
gautampranava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RANJITH KUMAR |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam
Pondicherry
India
Aarupadai veedu medical College and hospital, kirumampakam,cuddalore main road, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8056289625 |
| Fax |
|
| Email |
ranjit9124@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical College and hospital, Kirumampakam , Puducherry , 636402 |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical College nd hospital |
| Address |
Aarupadai veedu medical College nd hospital, kirumampakam,cuddalore main road, puducherry |
| 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 S Praveen kumar |
Aarupadai veedu medical College and hospital |
Department of Anaesthesiology, First floor, A bock,cuddalore main road,
kirumampakam , Pondicherry.
Pondicherry
PONDICHERRY |
8903636680
praveenkumardpi97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical commitee aarupadai veedu medical college and hospital |
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 |
REVERSAL OF NEUROMUSCULAR BLOCKADE BY Inj NEOSTIGMINE WITH Inj GLYCOPYROLATE. |
Patient undergoing Laparoscopic cholecystectomy under General Anesthesia at the time of reversal we will give Inj Neostigmine with inj Glycopyrolate to access the recovery time from neuromuscular blockade. |
| Comparator Agent |
REVERSAL OF NEUROMUSCULAR BLOCKADE BY INJ.SUGAMMADEX. |
Patient undergoing Laparoscopic cholecystectomy under General Anesthesia at the time of reversal we will give Inj Sugammadex to access the recovery time from neuromuscular blockade. |
| Intervention |
REVERSAL OF NEUROMUSCULAR BLOCKADE IN GENERAL ANESTHESIA. |
Patient undergoing Laparoscopic cholecystectomy under General Anesthesia at the time of reversal we will give Inj Neostigmine with inj Glycopyrolate or Inj Sugammadex to access the recovery time from neuromuscular blockade.Total duration of intervention is about approximately 5 to 15 min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age : 18 to 65 years
2. ASA I, ASA II and ASA III
3. Elective Laparoscopic cholecystectomy surgery
4. MPG I, II |
|
| ExclusionCriteria |
| Details |
1.Patients with neuromuscular diseases
2.Patients using medications that influence
neuromuscular functions (e.g:-Calcium channel
blockers, magnesium supplements , phenytoin,
amino glycoside)
3.Electrolytes abnormalities
4.Hepatic or renal insufficiency
5.Patients with known allergies to medications
used in the study
6.Laparoscopic cholecystectomy converted to open
surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Time to recovery provided by Sugammadex and Neostigmine in Vecuronium
induced Neuromuscular blockade in patient undergoing laparoscopic cholecystectomy. |
5 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To moniter Hemodynamics changes with extubation. |
4 hrs |
| To moniter for any Residual neuromuscular blockade. |
6 hrs |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
05/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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 - NO
|
|
Brief Summary
|
Acetylcholinesterase inhibitors such as Neostigmine, have traditionally been used for reversal of Neuromuscular blockade by Non depolarizing Neuromuscular blocking agents. However, these drugs have significant limitations such as inability to reverse profound and deep blockade (due to the ceiling effect of these agents), resulting in incomplete reversal and residual blockade, cardiovascular adverse effects, and undesirable autonomic responses.
Sugammadex is a modified γ-cyclodextrin works by encapsulating the molecules of the neuromuscular blockade agents Its unique mechanism of action is responsible for the rapid and efficient reversal of the deep neuromuscular blockade, without autonomic cholinergic side effects.
So we are comparing Time to recovery provided by Sugammadex and Neostigmine in Vecuronium induced Neuromuscular blockade in patient undergoing laparoscopic cholecystectomy. |