| CTRI Number |
CTRI/2025/08/092592 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Drug Combinations to Help Patients Breathe on Their Own Faster Faster After Surgery |
|
Scientific Title of Study
|
Effect Of Rocuronium- Sugammadex Versus Atracurium - Neostigmine On Time To Extubation: A Randomized Parallel Group 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 |
Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Dept. of Anesthesiology, All India Institute of Medical Sciences, Bibinagar, Hyderabad
Metropolitan region
Hyderabad
TELANGANA
508126
India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Dept. of Anesthesiology, All India Institute of Medical Sciences, Bibinagar, Hyderabad
Metropolitan region
TELANGANA
508126
India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Dept. of Anesthesiology, All India Institute of Medical Sciences, Bibinagar, Hyderabad
Metropolitan region
TELANGANA
508126
India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana, India, Pincode: 508126 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bibinagar |
| Address |
All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region,
Telangana, India, Pincode 508126 |
| 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 |
| Ayya Syama Sundar |
All India Institute of Medical Sciences, Bibinagar |
Room number G35 and G36, Operation
Theater Complex, Department of
Anaesthesiology, All India Institute of
Medical Sciences, Bibinagar,
Hyderabad Metropolitan Region,
Telangana-508126
Hyderabad
TELANGANA |
8179309677
sasyasyama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(AIIMS BBN-IEC) |
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 |
Atracurium-Neostigmine |
Patients will receive atracurium 0.5mg per kg ideal body weight for muscle relaxation for intubation. Neuromuscular blockade will be maintained with bolus doses of inj. atracurium 0.1 mg/kg (based on ideal body weight), administered upon the appearance of spontaneous movements or respiratory efforts. At the end of surgery, patients will receive neostigmine 50 mcg per kg + glycopyrrolate 10 mcg per kg, after appearance of spontaneous efforts, for reversal of muscle relaxation during extubation. Both drugs will be administered intravenously. |
| Intervention |
Rocuronium-Sugammadex |
Patients will receive rocuronium 0.6mg per kg ideal body weight for muscle relaxation for intubation. Neuromuscular blockade will be maintained with bolus doses of inj. rocuronium 0.15 mg/kg (based on ideal body weight), administered upon the appearance of spontaneous movements or respiratory efforts. Immdiately At the end of surgery and after application of surgical dressing, patients will receive consecutive doses of sugammadex 2 mg per kg, every 3 minutes, (up to a maximum of 16mg/kg) until patient meets extubation criteria, for reversal of muscle relaxation during extubation. Both drugs will be administered intravenously. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation. Estimated duration of surgery being 30 minutes to 3 hours. |
|
| ExclusionCriteria |
| Details |
Patient refusal. Requirement of post-operative mechanical ventilation. Anticipated difficult airway. Pregnant patients. Patients planned for extubation under deep planes of anesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to tracheal extubation from application of surgical dressing, in minutes. |
Time period measured between application of surgical dressing and removal of endotracheal tube after patient meets extubation criteria. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to patient shift out of operating room from tracheal extubation. |
Time period measured between tracheal extubation and patient leaving the operating room to the post-anaesthesia care unit. |
| Adverse events, if any |
up to twenty four hours after extubation. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/08/2025 |
| Date of Study Completion (India) |
14/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/11/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Introduction:Efficient anaesthesia reversal is essential for optimizing operating room (OR) time and patient outcomes. Rocuronium (reversed by sugammadex) and atracurium (reversed by neostigmine) are commonly used. Sugammadex offers faster reversal but is costly and often unavailable in resource-limited settings. Current studies focus on time from reversal agent administration, not from surgical completion, missing critical OR time delays.
This study addresses that gap by comparing time to extubation from end of surgery, evaluating clinical outcomes and cost-effectiveness, particularly in the Indian healthcare context.
Objectives:Primary Objective:
Compare time from surgical dressing to extubation between Rocuronium-Sugammadex (RS) and Atracurium-Neostigmine (AN) groups.
Secondary Objectives:
Time from extubation to OR exit
Incidence of postoperative adverse events (within 24 hours)
Rationale & Novelty:Sugammadex is new in India; its cost and lack of monitoring tools limit usage.
Previous studies measured reversal time from drug administration, not surgical end.
No Indian studies use clinical criteria for reversal timing.
The study offers a real-world, clinically relevant evaluation that may influence practice and cost management.
Hypothesis:Rocuronium-sugammadex leads to a shorter time to extubation from end of surgery compared to atracurium-neostigmine.
Methodology:Design: Randomized parallel group study
Duration: 12 months (8 months data collection, 2 months analysis & writing)
Population: 60 adult patients (30 per group), aged 19–60, ASA I–II, undergoing elective surgery under GA lasting 30 min–3 hrs
Randomization: 1:1 allocation
Intervention:
Group AN: Atracurium + Neostigmine-Glycopyrrolate (on spontaneous effort)
Group RS: Rocuronium + Sugammadex (immediately after dressing; repeated every 3 mins up to 16 mg/kg as needed)
Extubation Criteria: Awake, responsive, stable vitals, adequate spontaneous breathing
Post-op Monitoring: 24 hours for complications (desaturation, obstruction, re-intubation)
Sample Size:Although minimum of 4 patients (2 per group) was statistically sufficient, 30 per group were recruited to improve generalizability and allow robust analysis.
Expected Outcome:Faster extubation in the RS group could justify the higher drug cost by saving OR time, improving efficiency, reducing staff stress, and optimizing resource use — especially relevant for developing healthcare systems.
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