| CTRI Number |
CTRI/2024/05/067410 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Neostigmine as reversal agent in patients undergoing general anesthesia with Cis-atracurium |
|
Scientific Title of Study
|
Efficacy of neostigmine in reversal of neuromuscular blockade in patients undergoing general anesthesia using cisatracurium - a randomized controlled clinical 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 |
Dr. Amrita Panda |
| Designation |
Professor and Head of Department of Anesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Room number 6, Department of Anesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar-751024
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amrita.panda@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amrita Panda |
| Designation |
Professor and Head Of Department of Anesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Room number 6, Department of Anesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar- 751024
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amrita.panda@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Amrita Panda |
| Designation |
Professor and Head Of Department of Anesthesiology |
| Affiliation |
Kalinga Institute of Medical sciences |
| Address |
Room number 6, Department of Anesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar-751024
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amrita.panda@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences - 751024 |
|
|
Primary Sponsor
|
| Name |
Dr Deepshikha Patangia |
| Address |
Department of anesthesiology, Kalinga Insitute of Medical Sciences, Bhubaneswar -751024, ODISHA |
| Type of Sponsor |
Other [Self ] |
|
|
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 Deepshikha Patangia |
Kalinga Institute of Medical Sciences |
Ot complex, 3rd floor, Kalinga Institute of Medical Sciences, Bhubaneswar - 751024
Khordha
ORISSA |
09437554889
2387002@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.05 mg/kg Neostigmine diluted to 10ml with normal saline |
Will be administered intravenously at the time of reversal. |
| Comparator Agent |
10ml normal saline |
Will be administered intravenously at the time of reversal |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 20 to 60 years
2.American Society of Anesthesiology (ASA) physical status I and II
3.Scheduled for elective surgery under general anesthesia
4.Duration of surgery less than 3 hours.
|
|
| ExclusionCriteria |
| Details |
1.Patients with a BMI ≥ 25 kg/m2
2.Pregnant or lactating women
3.With significant hepatic or renal dysfunction
4.With respiratory pathologies like COPD or is a chronic smoker
5.Family history of malignant hyperthermia
6.Any known allergy to one of the drugs used in this protocol or on recent use of sedatives, anti-depressants
7.Inability to assess muscle strength or TOF count (neuromuscular disease).
|
|
|
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 |
| To assess the time (in minutes) needed to achieve a TOF ratio of 0.9 after administering the study drug. |
1. Preoperatively
2. Induction
3. Intubation
4. Extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess clinical parameters of postoperative recovery
a. Sustained head lift(yes/no)
b. Sustained hand grip(yes/no)
c. Exhaled Tidal volume(in ml)
2. To assess length of Post Anesthesia Care Unit stay (in minutes)
|
1. Pre operatively
2. Induction
3. Intubation
4. Extubation |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="2"
Months="0"
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
|
Neuromuscular blocking agents (NMBAs) are widely used to provide muscle relaxation for endotracheal intubation, mechanical ventilation and surgical procedures. They facilitate airway management and ensure optimal surgical conditions. Incomplete reversal can lead to impaired pharyngeal function, severe hypoxemia and airway obstruction. Antagonism of non-depolarising neuromuscular block is often facilitated with neostigmine, an anticholinesterase. Neostigmine in a dose of 70mcg/kg, if used as reversal, takes 15 to 20 minutes to achieve a TOF ratio of 0.90 in 95% of the patients, that is for complete reversal. Without reversal, it will take approximately 90 to 120 minutes to reverse the effects of an intermediate-acting neuromuscular blocking drug like Cis-atracurium. Cis-atracurium undergoes Hoffman elimination and does not usually require antagonism. My study aims to show that there is a significant difference in the time taken to achieve complete reversal with or without Neostigmine, by assessing the time needed to achieve a TOF ratio of 0.9 after injecting the study drug, PACU stay time and clinical parameters of post-operative recovery. |