| CTRI Number |
CTRI/2024/09/074213 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| 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
|
clinical study comparing the effects of two drugs Neostigmine and Sugammadex on heart rate and blood pressure in healthy patients undergoing nasal sinus surgeries |
|
Scientific Title of Study
|
Comparing the effect of Neostigmine and Sugammadex on hemodynamic parameters in patients undergoing Functional Endoscopic Sinus Surgery |
| 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 Farwa Al Bathool |
| Designation |
PG Resident |
| Affiliation |
Dr Moopens Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
Dr MOOPENS MEDICAL COLLEGE, NASEERA NAGAR,
MEPPADI, WAYANAD.
Wayanad
KERALA
673577
India |
| Phone |
9633313536 |
| Fax |
|
| Email |
farwa.awraf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Tegginamath |
| Designation |
Professor |
| Affiliation |
Dr Moopens Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
Dr MOOPENS MEDICAL COLLEGE, NASEERA NAGAR,
MEPPADI , WAYANAD.
Wayanad
KERALA
673577
India |
| Phone |
9243507325 |
| Fax |
|
| Email |
shraddhakrupa27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek R |
| Designation |
Associate Proffesor |
| Affiliation |
Dr Moopens Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
Dr MOOPENS MEDICAL COLLEGE, NASEERA NAGAR,
MEPPADI , WAYANAD.
Wayanad
KERALA
673577
India |
| Phone |
7795460038 |
| Fax |
|
| Email |
abhishek.r@drmoopensmc.ac.in |
|
|
Source of Monetary or Material Support
|
| Dr.Moopens Medical College, Naseera nagar, Meppadi ,Wayanad , Kerala , 673577 |
|
|
Primary Sponsor
|
| Name |
Dr Moopens Medical College |
| Address |
Naseera nagar meppadi wayanad Kerala 673577 |
| Type of Sponsor |
Private 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 |
| Dr Farwa al bathool |
Dr.MOOPENS MEDICAL COLLEGE |
DEPARTMENT OF ANAESTHESIOLOGY, 7TH FLOOR OT COMPLEX, NASEERA NAGAR,MEPPADI,WAYANAD,673577
Wayanad
KERALA |
9633313536
farwa.awraf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.MOOPENS MEDICAL COLLEGE |
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 |
its a drug classified as anti-cholinesterase. used to reverse steroidal non depolarizing muscle relaxant in general anesthesia.
dose is 0.05mg/kg given intravenously at the end of surgery.at the end of surgery. the effect of drug on heart rate , blood pressure , systolic blood pressure, diastolic blood pressure, mean arterial pressure , oxygen saturation and QTc interval on ECG will be monitored for every minute first ten minutes ,every ten minutes for first hour and every hourly for 24 hours |
| Intervention |
Sugammadex |
its a drug under classification of cyclodextrin, used to reverse steroidal non depolarizing muscle relaxant in general anesthesia.
dose is 2mg/kg intravenously. the drug will be administered at the rate of 0.2ml/sec ,at the end of surgery. the effect of drug on heart rate , blood pressure , systolic blood pressure, diastolic blood pressure, mean arterial pressure , oxygen saturation and QTc interval on ECG will be monitored for every minute first ten minutes ,every ten minutes for first hour and every hourly for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
healthy patients with no comorbidities.
patients undergoing elective endoscopic nasal sinus surgeries. |
|
| ExclusionCriteria |
| Details |
patients with any other comorbidities.
patients with cardiopulmonary , renal or hepatic impairments.
patients with coagulation disorders.
patients with history or ongoing drug abuse or alcohol abuse |
|
|
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 compare the effect of sugammadex and neostigmine on heart rate , blood pressure, mean arterial pressure, oxygen saturation, and QTc interval on ECG. |
every minute for first 10 minutes, every 10 minutes for first hour , hourly intervals for 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to assess the incidence of reintubation.
to assess any adverse effects like -anaphylactic reactions, post extubation stridor, post operative nausea vomiting. |
every hourly for 24 hours after the surgery |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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 4 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this study we are comparing the effect of two drugs sugammadex and neostigmine. both drugs are being used in reversing steroidal non depolarizing muscle relaxants in general anesthesia.
In this study we will be comparing its effects on heart rate , blood pressure , systolic blood pressure, diastolic blood pressure ,mean arteriaL pressure, oxygen saturation , QTc interval on ECG.
study will be done among total 112 patients , with 56 patient in each group.
we are doing this study since sugammadex is a newer agent , and comparing with neostigmine which is being routinely used as a reversal agent for neuromuscular blockage in general anesthesia. |