| CTRI Number |
CTRI/2024/08/072649 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of intravenous Dexmedetomidine and Midazolam as premedication in paediatric patients undergoing surgery |
|
Scientific Title of Study
|
Comparison of effect of intravenous Dexmedetomidine and Midazolam on preoperative sedation in paediatric patients undergoing elective surgery under general anaesthesia |
| 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 Nazrana Nasrin Sultana |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital, Guwahati |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Guwahati, Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9854065965 |
| Fax |
|
| Email |
sananazrana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susmita Borah |
| Designation |
Assistant Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Guwahati, Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9435168621 |
| Fax |
|
| Email |
susmitaborah1971@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nazrana Nasrin Sultana |
| Designation |
Post Graduate Trainee |
| Affiliation |
gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Guwahati, Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9854065965 |
| Fax |
|
| Email |
sananazrana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Kamrup Metro, 781032, Assam |
|
|
Primary Sponsor
|
| Name |
Dr Nazrana Nasrin Sultana |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital. Bhangagarh, Guwahati, Kamrup Metro, 781032 |
| 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 Nazrana Nasrin Sultana |
Gauhati Medical College and Hospital |
Department of Anesthesiology and Critical Care, Guwahati, 781032
Kamrup
ASSAM |
9854065965
sananazrana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gauhati Medical College and Hospital, Guwahati |
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 |
Inj Dexmedetomidine |
1mcg/kg in 100ml NS over 10 minutes before induction |
| Comparator Agent |
Inj Midazolam |
Inj Midazolam 0.05mg/kg in 100ml NS over 10 minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients with ASA grade 1 undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Obese patients with BMI more than 30
2. Patients with anticipated difficult airway
3. Patients with hepatic or renal dysfunction
4. Patients with known allergy to study drugs
5. Patients with sedation score less than 5 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the sedation score of IV Dexmedetomidine and Midazolam |
0 minutes, 10 minutes, at the time of extubation and 2 hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the mask acceptance score in the two groups |
At 10 minutes after drug administration just before induction |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/08/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sananazrana@gmail.com].
- For how long will this data be available start date provided 15-10-2024 and end date provided 15-10-2054?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
One of the challenges in paediatric anaesthesia is to minimize distress for children in the OT room environment and to facilitate smooth induction of anaesthesia. This is often accomplished by prior administration of a sedative drug before transfer to the Operation room.Midazolam is the most common drug used for this purpose.(1) This is due to its sedative and anxiolytic properties (2). However, undesirable properties like restlessness and respiratory depression have made it a less than ideal premedication (3). Dexmedetomidine is a newer alpha agonist with a more selective action on alpha adrenoceptor and a shorter half life (4). It provides sedation, anxiolysis and analgesia without respiratory depression (5). The purpose of this study is to compare intravenous Midazolam and Dexmedetomidine as premedication in paediatric age group. The null hypothesis of our study is that there is no significant difference between effect of intravenous Midazolam and Dexmedetomidine on preoperative sedation in paediatric patients undergoing elective surgery under general anaesthesia. The study will be carried out in different Operation theatres of GMCH on paediatric patients in the age group 5-12 years.
References: 1. Kain ZN, Caldwell-Andrews AA, Krivutza DM,Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anaesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: Results of a follow-up national survey. Anesth Analg. 2004;98:1252-9 2. marshall J, Rodarte A, Blumer J, Khoo KC, Akbari B, Kearns G. Pediatric pharmacodynamics of midazolam oral syrup. Pediatric Pharmacology Research Unit Network. J Clin Pharmacol. 2000;40:578-89 3. Kanegaye JT, Favela JL, Acosta M, Bank DE. High dose rectal Midazolam for pediatric procedures: A randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003;19:329-36 4. Petroz GC, Sikich N, James M, van Dyk H, Shafer SL, Schily M. A phase 1, two-center study of the pharmacokinetics and pharmacodynamics of dexmedetomidine in children. Anesthesiology. 2006;105:1098-110 5. June JH, Kim KN, Kim JY, Song SM: The effects of intranasal Dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017, 9:947-961. 10.1007/s12630-017 |