| CTRI Number |
CTRI/2025/06/088139 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of dividing the dose of sugammadex on reducing emergence cough |
|
Scientific Title of Study
|
Impact of dividing the dose of sugammadex on reducing emergence cough - A prospective, randomized, double-blinded study |
| 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 Simone Anthony Dmello |
| Designation |
Secondary DNB student |
| Affiliation |
Fortis Hospitals Limited |
| Address |
Level 2, Department of Anaesthesiology, Fortis Hospitals Limited, Mulund-Goregaon Link Road, Bhandup (west), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400080
India |
| Phone |
9833621906 |
| Fax |
|
| Email |
simone.dmello.sd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Shetty |
| Designation |
Head of Department, Department of Anaesthesiology |
| Affiliation |
Fortis Hospitals Limited |
| Address |
Level 2, Department of Anaesthesiology, Fortis Hospitals Limited, Mulund-Goregaon Link Road, Bhandup (west), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400080
India |
| Phone |
9821076279 |
| Fax |
|
| Email |
vijay.drvijays@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Kulkarni |
| Designation |
Consultant Anaesthesiologist, Department of Aanesthesia |
| Affiliation |
Fortis Hospitals Limited |
| Address |
Level 2, Department of Anaesthesiology, Fortis Hospitals Limited, Mulund-Goregaon Link Road, Bhandup (west), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400080
India |
| Phone |
9820789650 |
| Fax |
|
| Email |
amrutaajgaonkar9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fortis Hospitals Limited, Mulund-Goregaon Link Road, Bhandup (west), Mumbai 400080, MAHARASHTRA, India |
|
|
Primary Sponsor
|
| Name |
Fortis Hospitals Limited |
| Address |
Mulund-Goregaon Link Road, Bhandup (west), Mumbai 400080 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Simone Anthony Dmello |
Fortis Hospitals Limited |
Operation Theatre Complex, Level 2, Department of Anaesthesiology, Mulund-Goregaon Link Road, Bhandup (west), Mumbai 400080
Mumbai (Suburban)
MAHARASHTRA |
9833621906
simone.dmello.sd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee |
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 |
Sugammadex |
2 mg/kg dose intravenous over 10 seconds given as single bolus before extubation |
| Intervention |
Sugammadex |
2 mg/kg given as divided dose of 1 mg/kg intravenous over 10 seconds before extubation and remaining 1 mg/kg intravenous over 10 seconds immediately after extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologists (ASA) physical status 1 – 3
2. Body mass index (BMI) less than 35kg/m2
3. Scheduled to undergo elective surgery under general anaesthesia with endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Past history of allergy
3. History of neuromuscular disease, coagulopathy
4. Patients with severe hepatic or renal impairment
5. Haemodynamically unstable patients
6. Patients who are planned to remain intubated and mechanically ventilated or tracheostomized postoperatively
7. Pregnant or lactating women
8. Patients with active cough or history of smoking
9. History of asthma or chronic obstructive pulmonary disease
10. Difficult intubation requiring more than 3 attempts |
|
|
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 measure and compare the incidence and severity of emergence cough between two groups of patients:
1. One group (A) receiving the total dose of sugammadex (2 mg/kg) intravenous over 10 seconds prior to extubation, and
2. The other group (B) receiving half of the total 2 mg/kg dose (1 mg/kg intravenous over 10 seconds) before extubation, and the remaining half (1 mg/kg intravenous over 10 seconds) immediately after extubation. |
1. Emergence time (time period from discontinuation of all anaesthetic agents to administration of intravenous reversal agent sugammadex)
2. Extubation time (time period from intravenous administration of reversal agent sugammadex to the time at which tracheal extubation is performed)
3. 1 minute after extubation
4. 5 minutes after extubation
5. 60 minutes in the Post Anaesthesia Care Unit (PACU). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure & compare the incidence of post-extubation desaturation (oxygen saturation less than 90% on facemask) between the two groups |
1. 1 minute after extubation
2. 5 minutes after extubation |
| To measure & compare post-extubation sedation levels graded with Ramsay Sedation Score (RSS). |
1. 1 minute after extubation
2. 5 minutes after extubation
|
| Incidence of severe delayed post-operative cough |
60 minutes in the Post Anaesthesia Care Unit (PACU) |
| Incidence of post-operative sore throat |
60 minutes in the Post Anaesthesia Care Unit (PACU) |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/06/2025 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [simone.dmello.sd@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Sugammadex is a modified gamma cyclodextrin which selectively binds to the aminosteroid class of non-depolarizing neuromuscular blocking agents, with the highest affinity for encapsulating rocuronium. It has been studied extensively and emerged as a superior reversal agent. Despite it’s safe clinical profile, the most common adverse reaction with sugammadex reversal is emergence cough. In anaesthesia, it is desirable to avoid sudden cough on emergence as it is associated with several adverse outcomes. In our study, we aim to demonstrate a reduction in the incidence and severity of emergence cough by dividing the dose of sugammadex, which will help us improve post-operative clinical outcomes. Our study is a Randomized, double-blinded, prospective, single centre study, where our primary outcome is to measure and compare the incidence and severity of emergence cough between two groups of patients:1. One group (A) receiving the total dose of sugammadex (2 mg/kg) prior to extubation, and 2. The other group (B) receiving half of the total 2 mg/kg dose (1 mg/kg) before, and the remaining half (1 mg/kg) immediately after extubation. We will also measure and compare secondary outcomes such as any incidence of post-extubation desaturation (oxygen saturation less than 90% on facemask), post-extubation sedation levels graded with Ramsay Sedation Score (RSS), any severe delayed post-operative cough and post-operative sore throat between the two groups. |