| CTRI Number |
CTRI/2025/08/092425 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of safety and efficacy of using less muscle relaxant and reversal versus TOF versus traditional muscle relaxant and reversal in laparoscopic gall bladder removal surgery |
|
Scientific Title of Study
|
Comparison of safety and efficacy of restricted use of muscle relaxant and TOF (Train of Four) based reversal with conventional use of muscle relaxant and reversal in laparoscopic cholecystectomy: A Prospective randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Singam Geetha |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Det of Anaesthesia
OT3
specality block
Nims
Panjagutta
Hyderabad
Telangana
Hyderabad
TELANGANA
50082
India |
| Phone |
09441043075 |
| Fax |
|
| Email |
singamgeetha11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Singam Geetha |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Det of Anaesthesia
OT3
specality block
Nims
Panjagutta
Hyderabad
Telangana
Hyderabad
TELANGANA
50082
India |
| Phone |
09441043075 |
| Fax |
|
| Email |
singamgeetha11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Singam Geetha |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Det of Anaesthesia
OT3
specality block
Nims
Panjagutta
Hyderabad
Telangana
Hyderabad
TELANGANA
50082
India |
| Phone |
09441043075 |
| Fax |
|
| Email |
singamgeetha11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Singam Geetha |
| Address |
Dept of Anaesthesia
OT3
specality block
Nims
Panjagutta
Hyderabad
Telangana |
| 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 |
| Singam Geetha |
Nizams Institute of Medical Sciences |
Dept of Anaesthesia
OT3
specality block
Nims
Panjagutta
Hyderabad
Telangana
Hyderabad
TELANGANA |
09441043075
singamgeetha11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nims institutional Ethics Commitee |
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 |
Group F : Fixed dose group |
will receive weight based dose of muscle relaxant atracurium with fixed dose of neostigmine |
| Comparator Agent |
Group Variable: Group V |
will receive restricted use of atracurium, with neostigmine titrated to residual block using TOF |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1-2 ,
18-65 yr age,
both gender,
BMI :18.5 to 27 kg/m2,
Duration of surgery: 1hr to 3 hr
Elective surgery
|
|
| ExclusionCriteria |
| Details |
A history of myopathy, polyneuropathy,
Severe kidney or liver diseases,
Thyroid disorders,
Myasthenia or stroke,
Patients treated with amino glycosides or magnesium or any medication known to influence neuromuscular function,
Unexpected difficult airway,
Pregnancy, breastfeeding,
Emergency surgery,
Chronic obstructive pulmonary disease,
CAD, Electrolyte imbalance,
Intra operative airway complication-bronchospasm and aspiration
|
|
|
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 |
1. Feasibility of providing adequate surgical conditions by maintaining entropy of 40-50 and without dense neuromuscular blockade.
2. Comparison of surgical conditions and atracurium requirement between use of liberal dose of atracurium to achieve dense neuromuscular block (group F) and restricted use of atracurium while maintain adequate depth of anesthesia (group V)
3. Comparison of dose of neostigmine for reversal of NMBD with a liberal dose of neostigmine administered based on clinical judgment with administration of neostigmine titrated to TOF ratio.
|
intraop |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of maximum intra abdominal pressure, peak airway pressure at highest intra abdominal pressure, airway Compliance at highest intra abdominal pressure, requirement of isoflurane, requirement of intraoperative fentanyl between the groups.
2. Comparison of TOF ratio at the time of decision of reversal and time for extubation,
3. Comparison of TOF ratio at extubation and in the post extubation period,
4. Comparison of postoperative pulmonary complications between the groups,
5. Comparison of VAS and RSS score between the groups,
6. Comparison of change in muscle grip strength and PEFR from baseline, time required to sit and stand between the groups.
|
Intraop, postop 15min,1hr,,3hr and 24 hr |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/08/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
After ethics commitee approval and CTRI registration, This prospective randomised controlled trial will include 40 patients undergoing lap cholecystectomy under GA dividedinto 2 groups : Group F to receive weight based muscle relaxant and atracurium and fixed dose of neostigmine and group V : to receive restricted muscle relaxant anf TOF guided neostigmine. under entropy guidance. Intraop surgical conditionbs, airway pressure, muscle relant and neostigmine dose, extubation, recovery time, postop muscle grip strength, peak expiratory flow rate, situp, stan and postop pulmonary complications will be assessed |