| CTRI Number |
CTRI/2024/07/070725 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Sugammadex and Neostigmine in adult patients undergoing cardiac surgeries for on table extubation |
|
Scientific Title of Study
|
Comparison of sugammadex and neostigmine in adult patients undergoing on table extubation after elective cardiac surgery under combined general and high spinal anaesthesia - A randomized controlled trial 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 |
Sunder Lal Negi |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care 4th floor A Block Nehru Hospital Post Graduate Institute of Medical Education and Research Chandigarh India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888446388 |
| Fax |
|
| Email |
dr.sundernegi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunder Lal Negi |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care 4th floor A Block Nehru Hospital Post Graduate Institute of Medical Education and Research Chandigarh India
CHANDIGARH
160012
India |
| Phone |
9888446388 |
| Fax |
|
| Email |
dr.sundernegi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunder Lal Negi |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care 4th floor A Block Nehru Hospital POST Graduate Institute of Medical Education and Research Chandigarh India
CHANDIGARH
160012
India |
| Phone |
9888446388 |
| Fax |
|
| Email |
dr.sundernegi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care unit, Post Graduate Institute of Medical Education and Research, Chandigarh, India, 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Sector 12, Chandigarh, India, 160012 |
| 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 Dolcy Kapoor |
Post Graduate Institute of Medical Education and Research |
4th floor Main OT Complex Advanced Cardiac Centre Department of Anaesthesia and Intensive care PGIMER
Chandigarh
CHANDIGARH |
8168912006
dolcykapoor24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research Chandigarh Institutional Ethics Committee (Intramural) |
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 |
Neostigmine |
Neostigmine 50 mics/kg administered intravenously before extubation when TOF attained is more than 0.9 |
| Intervention |
Sugammadex |
Sugammadex 2mg/kg administered intravenously before extubation after tof attained more than 0.9 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective cardiac surgery with CPB planned for on table extubation
ASA classification 1-3 |
|
| ExclusionCriteria |
| Details |
Allergic to Sugammadex or neostigmine or having any contraindications
Emergency cardiac surgery
Surgery under moderate to deep hypothermia
Patient not giving written informed consent
Patient with ejection fraction less than 30%
ASA classification more than III |
|
|
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 |
| The time interval from administering the reversal agent to the extubation. |
immediately |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to attain TOF more than 0.9.
Residual paralysis (TOF less than 0.9)
Respiratory complications (hypoxemia, hypercarbia),
Reintubation within 2 hours of extubation
Prolonged ICU stay duration
Requirement of non-invasive ventilation in ICU. |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="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
|
This study is a randomised, double blinded, parallel group, single centre trial comparing Sugammadex and Neostigmine in adult patients undergoing on table extubation after elective cardiac surgery under combined general and high spinal anaesthesia. The primary outcome will be the time interval from administering the reversal agent to extubation. The secondary outcomes will be time to attain TOF more than 0.9, residual paralysis (TOF less than 0.9), respiratory complications (hypoxemia, hypercarbia), reintubation within 2 hours of extubation, prolonged ICU stay duration, requirement of non-invasive ventilation in ICU within 48 hours. |