| CTRI Number |
CTRI/2025/07/091306 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs used for reversal of muscle blockade in elderly patient undergoing rigid bronchoscopy |
|
Scientific Title of Study
|
Comparison of recovery characteristics of sugammadex versus neostigmine in the elderly patient undergoing rigid bronchoscopy: A randomised 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 |
Paras Khadayat |
| Designation |
Junior resident |
| Affiliation |
All india institute of medical sciences- Rishikesh |
| Address |
All india institute of medical sciences- Rishikesh,Department of Anaesthesiology, Rishikesh,Veerbhadra, Dehradun, Uttrakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9634043550 |
| Fax |
|
| Email |
connectparas123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mridul Dhar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences- Rishikesh- Rishikesh |
| Address |
All India Institute of Medical Sciences- Rishikesh-Rishikesh,Department of Anesthesiology, Veeerbhadra, Rishikesh, Dehradun, Uttrakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mridul Dhar |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences-Rishikesh |
| Address |
All india institute of medical sciences- Rishikesh,Department of Anaesthesiology Veeerbhadra road, Rishikesh, Dehradun,Uttrakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Veerbhadra road,near Barrage Pahsulok Uttrakhand 249203 |
| 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 Paras Khadayat |
All India Institute of Medical sciences- Rishikesh |
All India Institute of Medical sciences- Rishikesh, Department of Anaesthesiology, Virbhadra, Dedrahun Uttrakhand
Dehradun
UTTARANCHAL |
9634043550
connectparas123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Aiims-Rishikesh |
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 |
Group A will receive sugammadex as reversal agent |
Group A participants will receive 2mg/kg of Sugammadex IV at the end of surgery after achieving 1-2 TOF count, or 4 mg/Kg when no twitch responses to TOF stimulation. |
| Comparator Agent |
Group B participants will receive neostigmine for muscle blockade reversal |
Group B participants will receive 0.05mg/kg of Neostigmine and 0.01mg/kg glycopyrrolate IV for muscle blockade reversal at the end of surgery when TOF ratio 0.4 or TOF count 2-3. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age: more than or equal to 60 years,ASA class I - III, all patients undergoing diagnostic or therapeutic bronchoscopy,patients giving consent for procedure will be considered for the study |
|
| ExclusionCriteria |
| Details |
1.Patient has already undergone any thoracic surgery in the past
2. Patient with ventilated support
3. Severe cardiac diseases
4. Known previous allergy to any drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extubation time in the elderly patient undergoing rigid bronchoscopy |
At time of extubation of trachea |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare perioperative vitals between the groups ,to compare any complications following administration of of Sugammadex and Neostigmine such as hypotension, laryngospasm, apnea, pneumonia, atelectasis etc
and to compare postoperative breath-holding time (BHT) following neuromuscular blockade reversal with Sugammadex versus Neostigmine, measured at 15 and 30 minutes after extubation, in comparison to preoperative BHT |
During intraoperative period and 1 hour of post extubation in the post anaesthesia care unit |
|
|
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)
|
01/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
All eligible participants will be seen the primary investigator one day prior to surgery and written informed consent will be taken. NPO instructions will be explained to the patient. On the day of surgery, Elderly will receive IV midazolam pre-operatively 0.5 mg/kg if needed or requested, 20-30 minutes before induction. ASA standards monitoring -oxygen saturation probe (SPO2), ECG, NIBP will be attached simultaneously. Intravenous induction will be done by IV fentanyl (1-2 µg/kg) followed by IV Propofol (2-2.5 mg/kg) or Etomidate (0.2-0.6mg/kg) followed by muscle relaxant Rocuronium (0.4-0.6 mg/kg). A rigid bronchoscope with side ventilation port will be used for mechanical ventilation. Maintenance of anesthesia will be by sevoflurane to achieve approximately 0.8-1 MAC. Fentanyl will be repeated as per clinical requirement in 0.5 µg/kg aliquots. This will be documented. Rocuronium maintenance doses will be guided by neuromuscular monitoring (Target of 0-1 TOF count). Intraoperative outcomes and drug requirements will be measured. At the end of surgery, - Group A participants will receive 0.05mg/kg of Neostigmine and 0.01mg/kg glycopyrrolate IV for muscle blockade reversal at the end of surgery when TOF ratio <0.4 or TOF count 2-3.
- Group B participants will receive 2mg/kg of Sugammadex IV at the end of surgery after achieving 1-2 TOF count, or 4 mg/Kg when no twitch responses to TOF stimulation.
Extubation time is calculated from the time sugammadex or neostigmine is given till TOF>0.9 is achieved in patient for extubation Haemodynamic and clinical parameters will be measured throughout the surgery and in the PACU. All elderly will be assessed for post pulmonary complication in PACU for 1 hour and in ward till patient is discharged from hospital.
|