| CTRI Number |
CTRI/2025/05/086936 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Recovery from Muscle Relaxants and Their Reversal: Rocuronium with Sugammadex vs. Cisatracurium with Neostigmine in Laparoscopic Surgery under General Anesthesia at SMS Medical College, Jaipur.
|
|
Scientific Title of Study
|
A Randomized Comparative Study for Recovery of Neuromuscular Blockade And Reversal Using Rocuronium And Sugammadex versus Cisatracurium And Neostigmine For Laparoscopic Surgery Under General Anaesthesia at SMS Medical college Jaipur. |
| 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 Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College And Hospital |
| Address |
Department of Anaesthesia SMS Medical College and Hospital Jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College And Hospital |
| Address |
Department of Anaesthesia SMS Medical College and Hospital Jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Nayak |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College And Hospital |
| Address |
Department of Anaesthesia SMS Medical College And Hospital
Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9902666425 |
| Fax |
|
| Email |
adityanyk.97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical college Jaipur . |
|
|
Primary Sponsor
|
| Name |
Sawai Mansingh Medical College and Hospital |
| Address |
Department of Anaesthesiology ,Second floor, Dhanvatri Building , JLN Marg ,Jaipur. |
| Type of Sponsor |
Government 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 Indu Verma |
General Surgery OT-2 Complex, SMS Medical College And Hospital |
Department of Anaesthesia, 2nd floor Dhanvantri Complex , SMS Medical College And Hospital Jaipur
Jaipur
RAJASTHAN |
9413622967
dr.induverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office Of Ethics Committee SMS Medical College And Hospital Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Neostigmine |
After Completion of surgery Injection Neostigmine 0.07mg/kg will be administered after reappearance of respiratory movements. |
| Intervention |
Injection Sugammadex |
After Completion of Surgery Injection Sugammadex 2mg/kg will be administered after reappearance of Respiratory movements.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for laparoscopic surgery under general anaesthesia.
2. Patient willing to give informed written consent.
3. Adult Patients of either sex 18 to 60 years of age.
4. American society of Anaesthesiologist(ASA) physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Use of psychiatric medications and alcohol abuse.
2. A history of liver and kidney diseases.
3. Allergy or contraindications to use of study medications.
4. Patients requiring postoperative mechanical ventilation.
5. Patient should not be a part of any other study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is to measure how well a patient feels and recovers after surgery and anesthesia in areas of
Physical comfort (pain, nausea, sleep)
Emotional state (anxiety, mood)
Physical independence (movement, self-care)
Psychological support (feeling supported)
Pain and discomfort. |
Primary outcome is to measure how well a patient feels and recovers after surgery and anesthesia in areas of
Physical comfort (pain, nausea, sleep)
Emotional state (anxiety, mood)
Physical independence (movement, self-care)
Psychological support (feeling supported)
Pain and discomfort. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of Extubation
Time of first spontaneous breath
Length of Postanesthesia Care Unit PACU Stay
Postoperative Nausea & Vomiting
PONV |
Time of Extubation
Time of first spontaneous breath
Length of Postanesthesia Care Unit (PACU) Stay
Postoperative Nausea & Vomiting (PONV) Time of Extubation
Time of first spontaneous breath
Length of Postanesthesia Care Unit PACU Stay
Postoperative Nausea & Vomiting PONV |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2025 |
| 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="0"
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
|
A Randomized Comperative study for recovery of neuromuscular blockade and reversal using rocuronium and sugammadex versus cisatracurium and neostigmine for laparoscopic surgery under general anaesthesia in Department of Anaesthesia |