| CTRI Number |
CTRI/2023/07/055172 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
12/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate the Efficacy of Sugammadex in Reversing the effect of a Muscle Relaxant in Patients Undergoing Major Upper Abdominal Surgery: An Observational Study |
|
Scientific Title of Study
|
Evaluation of Efficacy of Sugammadex for Reversal of Neuromuscular Blockade in Patients Undergoing Major Upper Abdominal Surgery: An Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpi Misra |
| Designation |
Associate Professor |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9839932239 |
| Fax |
|
| Email |
drshilpi1980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpi Misra |
| Designation |
Associate Professor |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
|
| Fax |
|
| Email |
drshilpi1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiba Iqbal Ali |
| Designation |
Junior Resident |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8929729693 |
| Fax |
|
| Email |
drhibaiqbalali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar, Lucknow, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, gomtinagar, Lucknow, Uttar Pradesh, 226010 |
| 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 Shilpi Misra |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
OT 1, OT2 of Department of Surgical Oncology
OT3, OT4 of Department of Surgical Gastroenterology
Lucknow
UTTAR PRADESH |
9839932239
drshilpi1980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
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 |
| Intervention |
Sugammadex |
Dose - 2 mg/kg
Frequency - Once
Route - Intravenous |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Patients posted for major upper abdominal surgery |
|
| ExclusionCriteria |
| Details |
Refusal to consent
ASA 3, 4 and Emergency cases
Patients with preoperative respiratory involvement
BMI >30 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the time from administration of Sugammadex till extubation on the basis of Train of Four ratio 0.9 |
After administration of Reversal agent |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To detremine the risk of post operative residual paralysis using diaphragm ultrasound |
Preoperative baseline
10 minutes after extubation
30 minutes after extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/07/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
During general anesthesia muscle relaxants are given to faciliotate endotracheal intubation and for optimum surgical conditions. A complication may be post operative residual blockade during a prolonged surgical procedure. Intraoperatively Neuromuscular monitoring can be used to allow proper administration of the relaxant to decrease the incidence of post operative residual curarization. After the completion of the surgery we use a reversal agent as in this case, Sugammadex which has showed decreased incidence of the post operative complications related to residual blockade. Diaphragm Ultrasound (Thickening fractioning) and Neuromuscular monitoring (Train of Four ratio) will be the primary modalities we use to evaluate the efficacy of Sugammadex against the traditionally used reversal Neostigmine. |