| CTRI Number |
CTRI/2020/07/026726 [Registered on: 21/07/2020] Trial Registered Prospectively |
| Last Modified On: |
15/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial for comparison of commonly used drug to the drug plus Calcium gluconate for measuring speed of recovery from muscle relaxant |
|
Scientific Title of Study
|
Prospective randomized controlled trial for comparison of effect on neuromuscular blockade recovery between calcium gluconate coadministered with neostigmine and neostigmine only in pediatric patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gunjan Singh |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Chandimandir |
| Address |
Operation Theatre,
Department of Anaesthesiology and Critical Care,
Command Hospital Chandimandir, Panchkula
CH-69/3 Command Hospital Chandimandir - Panchkula
Panchkula
HARYANA
134107
India |
| Phone |
09612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjan Singh |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Chandimandir |
| Address |
Operation Theatre
Department of Anaesthesiology and Critical Care
Command Hospital
Chandimandir, Panchkula
CH-69/3 Command Hospital Chandimandir - Panchkula
Panchkula
HARYANA
134107
India |
| Phone |
09612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjan Singh |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Chandimandir |
| Address |
Operation Theatre, Department of Anaesthesiology,Command Hospital Chandimandir - Panchkula
CH-69/3 Command Hospital Chandimandir - Panchkula
Panchkula
HARYANA
134107
India |
| Phone |
09612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical Research Comittee, DGAFMS,108 E Church Road, North Block, Rakab Ganj, New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical Research Comittee |
| Address |
Armed Forces Medical Research Comittee, DGAFMS,108 E Church Road, North Block, Rakab Ganj, New Delhi 110001 (COMMAND HOSPITAL WESTERN COMMAND
CHANDIMANDR
PANCHKULA
HARYANA
13407)
|
| Type of Sponsor |
Other [GOVERNMENT HOSPITAL ] |
|
|
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 |
| Gunjan Singh |
Command Hospital Western Command |
Operation Theatre, Department of Anaesthesiology and Critical Care ,Command Hospital Chandimandir - Panchkula
Panchkula
HARYANA |
09612112136
gunjanafmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital Western Command |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Gluconate with neostigmine |
Calcium Gluconate will be administered at 5mg/kg with the reversal agent nestigmine the dosage of which will be same as 70 microgram per kilogram |
| Intervention |
Neostigmine |
Neostigmine will be administered as 70 microgram per kilogram of body weight stat dose as the reversal agent. Rest everything will be the same in both the groups |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age of 3 to 15 years
2. ASA I and II
|
|
| ExclusionCriteria |
| Details |
1. Suspected difficult airway
2. History of bronchial asthma, neuromuscular disease, hepatic or renal disease.
3. Clinically suspected hypercalcemia
4. Severe or significant congenital heart disease
5. Bleeding diathesis
6. History of allergies to glycopyrrolate or neostigmine
7. Parental refusal
8. Weight of less than 10 kg.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration between injecting reversal agent and TOFr more than 90%
|
3,5 and 10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative Recurarisation at 3,5 and 10 min interval of giving the reversal agent |
3,5 and 10 min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/08/2020 |
| 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
|
This study will help us to find out any advantage of using Calcium Gluconate with the reversal agent for speedy recovery from Muscle Relaxants |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Muscle relaxation is the
integral part of general anaesthesia for intubation in elective surgeries. Few studies are published regarding the role
of using calcium with reversal agents for faster recovery in adults only but there
is paucity of studies in pediatric group. After ethical clearance the plan is
to compare the effects of addition of calcium gluconate to the reversal agent
on the basis of train of four and BIS monitoring.. Using BIS monitoring for the
depth of anaesthesia will be useful to avoid the bias due to the depth of
anaesthesia.
After completion of surgery, as TOFc-4 (Train
of Four count) is achieved, patients will receive 70 µg/kg neostigmine and
20µg/kg glycopyrrolate. Calcium gluconate 5mg/kg will be given with neostigmine
and glycopyrrolate in the calcium group and normal saline in the control group.
Duration of recovery between giving the reversal agent and the train of four
ratio of 90 will be noticed and then compared. |