| CTRI Number |
CTRI/2024/12/078308 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of muscle recovery after giving two drugs sugammadex versus neostigmine in obese patients undergoing laparoscopic gynaecological surgeries |
|
Scientific Title of Study
|
Comparison between sugammadex and neostigmine in terms of
postoperative respiratory muscle strength recovery in obese patients undergoing
laparoscopic gynaecological surgery. A 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 |
Anakha S |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar, 801507
Patna
BIHAR
801507
India |
| Phone |
9778073331 |
| Fax |
|
| Email |
anakhakukkuseetharam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnish Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Room no:503,Department of anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
Drraj76pmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajnish Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Room no:503,Department of anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
Drraj76pmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Phulwari sharif,Patna, Bihar, India
801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science Patna |
| Address |
Department of anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar, India. 801507 |
| 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 Anakha S |
All India Institute of Medical Sciences, Patna |
Department of
Anesthesiology, B5B
OT Complex, IPD 5th
Floor, All India Institute
of Medical Sciences
PATNA, Phulwari
Sharif, Patna Patna,
Bihar 801507,
Patna
BIHAR |
9778073331
anakhakukkuseetharam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals between 18 and 60 years old with BMI greater than 30kg/m2 presenting to AIIMS
Patna for laparoscopic gynaecological surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine as reversal agent |
Sonographic assessments :
Lung, Diaphragm and
respiratory muscle thickness
ultrasonography will be
performed by using 2-5 MHZ
transducers. Images will be
obtained at 4 defined time
points: 1. In preoperative period
– Baseline 2. 30 min after
administration of reversal 3. 2 hr
after administration of reversal
Neostigmine will be given
intravenously in a single dose of
0.05mg/kg body weight along
with glycopyrrolate 0.02mg/kg
based on TOF ratio before
extubation |
| Intervention |
Sugammadex as reversal agent |
Sonographic assessments :
Lung, Diaphragm and
respiratory muscle thickness
ultrasonography will be
performed by using 2-5 MHZ
transducers. Images will be
obtained at 3 defined time
points: 1. In preoperative period
– Baseline 2. 30 min after
administration of reversal 3. 2 hr
after administration of reversal
Suggamadex will be given intravenously in a single dose of
2mg/kg based on TOF ratio
before extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients aged 18 to 60 years with BMI greater than 30kg/m2 undergoing laparoscopic gynaecological surgeries |
|
| ExclusionCriteria |
| Details |
1. Significant kidney disease
(stage 4 kidney disease or
higher).
2.Significant liver disease (Child
Pugh B or C class)
3. Allergic to neostigmine or
sugammadex.
4. Any history of a neuromuscular
disorder.
5. History of chronic obstructive
pulmonary disease.
6.Pregnancy or nursing women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the recovery of respiratory muscle strength using
thickening fraction of internal oblique |
calculated at 30 minutes and 120 minutes after
giving reversal agent and compare with baseline
values |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the post operative atelectasis by the
modified LUS score based on lung ultrasound.
To assess the recovery of diaphragm, by
assessing diaphragm excursion |
calculated at 30 minutes and 120 minutes after
giving reversal agent and compare with baseline
values |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/01/2025 |
| 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="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 - NO
|
|
Brief Summary
|
The incidence of postoperative residual curarization (PORC) has been reported to be as high as 45.2% in the post-anesthesia care unit. Adequate reversal of neuro muscular blockade is important to regain muscle strength in the post operative period. PORC can result in many adverse effects such as post operative hypoxemia, atelectasis and increased pulmonary complications. Sugammadex is proposed to provide better muscle reversal, however whether this translates into better muscle strength has not been evaluated well. Better post operative recovery of muscle strength could prevent post operative pulmonary complications (PPC). In a retrospective cohort matched, observational study, such complications were reported to be 30–50% lower after administration of sugammadex. This study will compare recovery of muscle strength after giving both the drugs. We will and also assess to what extent post-operative atelectasis depends upon muscle strength recovery in the post-operative period. We hypothesise that the lung ultrasound findings in the post operative period are likely to be better when Sugammadex is given and the improved muscle recovery with sugammadex could prevent atelectasis and postoperative pulmonary complications better |