| CTRI Number |
CTRI/2024/07/071709 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Sugammadex And neostigmine recovery indices |
|
Scientific Title of Study
|
Sugammadex and neostigmine recovery indices in pediatric patients undergoing adenotonsillectomy-A prospective randomized 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 |
DR VIRESH SHRISHAIL KANNURE |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
BLDE DU,SHRI.B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,VIJAYPURA |
| Address |
BLDE DU,SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,VIJAYPURA.
Bijapur
KARNATAKA
586103
India |
| Phone |
9767795564 |
| Fax |
|
| Email |
drvireshkannure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIDYA PATIL |
| Designation |
PROFESSOR |
| Affiliation |
BLDE DU,SHRI.B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,VIJAYPURA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,3 RD FLOOR,407 BLDE DU,SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,VIJAYPURA.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448131260 |
| Fax |
|
| Email |
Vidya.tambake@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VIDYA PATIL |
| Designation |
PROFESSOR |
| Affiliation |
BLDE DU,SHRI.B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,VIJAYPURA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY 3 RD FLOOR,407,BLDE DU,SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,VIJAYPURA.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448131260 |
| Fax |
|
| Email |
Vidya.tambake@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| SHRI B M PATIL MEDICAL COLLAGE BLDE DEEMED TO BE UNIVERSITY BIJAPUR 586103 |
|
|
Primary Sponsor
|
| Name |
VIRESH S KANNURE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,3 RD FLOOR,407,BLDE DEEMED TO BE UNIVERSITY BIJAPUR 586103 |
| 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 VIRESH KANNURE |
SHRI B M PATIL MEDICAL COLLEGE |
DEPARTMENT OF ANAESTHESIOLOGY,3 RD FLOOR,407 BLDE DU,SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,VIJAYPURA.
Bijapur
KARNATAKA |
9767795564
drvireshkannure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SBMPMC, VIJAYAPURA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, (2) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of sugammadex and Neostigmine to assess the recovery after extubation |
Group S- Inj. Sugammadex- 2mg/kg Intravenous administration over 10 seconds
Group N- Inj. Neostigmine - 0.05mg/kg Intravenous slow administration |
| Intervention |
Comparison of sugammadex and neostigmine to assess time required for extubation and postoperative parameters. |
2 hours, 4 hours and 6 hours of post extubation period. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1] 3-17 AGE GROUP PATIENTS POSTED FOR ADENOIDECTOMY
AND TONSILLECTOMY.
2] ASA GRADE I AND II. |
|
| ExclusionCriteria |
| Details |
1] ANY CARDIOVASCULAR AND HEPATIC IMPAIRMENT.
2] CREATININE CLEARANCE LESS THAN 30 MG/ML.
3] ALLERGIC TO ANY ANESTHETIC AGENT. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE POST OPERATIVE PARAMETER SUCH AS POST OP NAUSEA AND VOMITTING AFTER USING INJ.SUGAMMADEX |
ASSESSMENT DONE IMMEDIETLY, AFTER 2 HRS AND AFTER 6 HRS OF EXTUBATION. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TIME REQUIRED FOR EXTUBATION. |
FROM CUTTING THE INHALATIONAL AGENTS AND GIVING INJ SUGAMMADEX AS REVERSAL TO EXTUBATION. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
12/08/2024 |
| 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)
|
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
|
This the comparative study between two drugs such as sugammadex and neostigmine which are used for reversal agent of choice during general anaesthesia. The primary objective of the study is to compare the post-operative parameters (bradycardia, hypotension, hypertension, fever, dry mouth, respiratory depression, anaphylactic reaction.etc.) after using sugammadex and neostigmine as a reversal agent of choice. Secondary objective is to compare the time required for extubation after using sugammadex and neostigmine + glycopyrrolate. Sugammadex is a cyclodextrin based medicine used during general anesthesia to reverse the neuromuscular blocking effect of vecuronium as well as rocuronium. Its molecular structure comprises a modified γ-cyclodextrin core featuring hydrophilic outer surfaces and a lipophilic central cavity. This distinctive arrangement allows sugammadex to create complexes with the steroidal components of specific neuromuscular blockers.by doing so sugammadex does not act on acetylcholine receptors present on the neuromuscular junction and quickly reverse the neuromuscular blockage. Neostigmine is a widely recognized and frequently utilized reversal agent during general anesthesia. It operates as an acetylcholinesterase inhibitor, effectively acting on non-depolarizing neuromuscular blocking agents. This action allows neostigmine to counteract the effects of these agents by inhibiting the breakdown of acetylcholine, thereby promoting increased muscle contraction and reversing neuromuscular blockade. In this study we are giving sugammadex for one group of patients undergoing adenotonsillectomy and neostigmine for one group undergoing adenotonsillectomy they are randomized in two different groups by computer generated chit methods. Both drugs are given at the end of surgery once the procedure is over and different parameters are noted. Sugammadex is given as 2 mg/kg dose and neostigmine is given as 0.05 mg/kg. Muscle relaxant of choice in the study is vecuronium as sugammadex only acts on vecuronium and rocuronium. Inclusion criteria for study are – 1] Pediatric patient undergoing adenotonsillectomy, 2] Age group – 3-17 years, 3] ASA grade I and II. Exclusion criteria for study are – 1] Any cardiovascular hepatic impairment. 2] Creatinine clearance <30 mg/ml. |