| CTRI Number |
CTRI/2024/08/072317 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of oral clonidine with oral midazolam as pre-medication in paediatric patients in Sawangi, Maharashtra |
|
Scientific Title of Study
|
Comparison Of clonidine with midazolam as pre anaesthetic oral medication in paediatric patients in Sawangi, Maharashtra |
| 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 Shyamolima Bhuyan |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Maharashtra
Wardha MAHARASHTRA 442001 India |
| Phone |
9359008510 |
| Fax |
|
| Email |
shybhuyan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shyamolima Bhuyan |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Maharashtra
Wardha MAHARASHTRA 442001 India |
| Phone |
9359008510 |
| Fax |
|
| Email |
shybhuyan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shyamolima Bhuyan |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Maharashtra
Wardha MAHARASHTRA 442001 India |
| Phone |
9359008510 |
| Fax |
|
| Email |
shybhuyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinobha Bhave Rural Hospital, Sarwangi, Maharashtra 442001, India. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra- 442001, India |
| 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 Shyamolima Bhuyan |
Acharya Vinobha Medical College |
Department of Anaesthesia, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra Wardha MAHARASHTRA |
9359008510
shybhuyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
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 |
Clonidine |
Clonidine will be administered as preanaesthetic medication at a dose of 4 mcg/kg per orally for 120 minutes |
| Intervention |
Midazolam |
Midazolam will be administered as preanaesthetic medication at a dose 0.5 mg/kg per orally for 120 minutes |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 2-12 years
2. Patients posted for surgery under general anaesthesia
3. Patients whose parents/ guardians provide consent. |
|
| ExclusionCriteria |
| Details |
1.Patients less than 2 year of age
2.Patients more than 12 years of age
3. Weight of more than 95th percentile for age
4. Patients with a difficult airway
5. Patients with mental retardation
6. Patients with central nervous system disorders
7. Patients on anticonvulsants or sedative medications
8. Patients who will require additional sedation. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare oral clonidine with oral midazolam as preanaesthetic medication |
1. at separation
2. at venepuncture
3. at mask application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of haemodynamic status of patients recieving oral clonidine & oral midazolam |
1. at separation
2. at venepuncture
3. at mask application |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
31/08/2024 |
| 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 - NO
|
|
Brief Summary
|
The preoperative period is a
stressful period and a major source of anxiety for all patients especially in
the paediatric population. Preoperative anxiety in children is a natural
response that that produces a negative experience for both patient and parent
and thus warrants attention. An ideal pre anaesthetic medication should reduce
separation anxiety from the parent, allow for easy and smooth induction of
anaesthesia without causing prolongation of emergence or increasing post
operative nausea, vomiting and delirium. Oral premedication is commonly used in
paediatric population prior to surgery. The ideal pre anaesthetic agent ought
to have a fast and dependable onset, negligible results, quick recuperation and
ought to work with smooth acceptance of sedation
Midazolam is a water-soluble
benzodiazepine. It used as a preanaesthetic medication by several routes
including oral, intravenous, intranasal and intramuscular. It has sedative and
amnestic effects. Midazolam is the most commonly used oral premedication used
in children. Oral midazolam syrup (2 mg/ml) is effective for producing sedation
and anxiolysis at a dose of 0.25 mg/kg with minimal effects on ventilation and
oxygen saturation even when administered at doses as large
As 1 mg/kg (maximum, 20 mg).
Midazolam, 0.5 mg/kg administered orally 30 minutes before induction of
anesthesia, provides reliable sedation and anxiolysis in children without
producing delayed awakening. Although it is recommended that oral midazolam be
administered at least 20 minutes before surgery, there is evidence that
significant anterograde amnesia is present when 0.5 mg/kg orally is
administered 10 minutes before surgery.
Clonidine is partial α2
receptor agonist. Premedication with clonidine produces preoperative sedation
and anxiolysis in children. It also has analgesic properties, decreases
volatile anesthetic requirements and improves perioperative hemodynamic
stability. Although clonidine is not as common as midazolam as a premedication,
it is slowly gaining popularity. It also reduces the requirements for both
inhaled anesthetics during surgery as well as opioids in the postoperative
period. Major postoperative issues include pain, emergence
delirium, airway obstruction, and hypoventilation. Opioids for pain management can exacerbate
airway obstruction and hypoventilation and increase postoperative emesis.
Nonsteroidal anti-inflammatory Drugs such as ketorolac are not associated with
the respiratory depressant and emetic side effects of opioid administration,
but are associated with increased bleeding.Aim
This study aims to Compare the efficacy of oral midazolam as
a pre anaesthetic medication to oral clonidine in paediatric patients
undergoing tonsillectomy. |