| CTRI Number |
CTRI/2024/11/076923 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Three Methods to Decide When Kids Can Leave the Recovery Room After Laparoscopic Surgery with General Anesthesia |
|
Scientific Title of Study
|
Comparison of three scoring criteria to assess discharge from post anesthesia care unit in paediatric patients undergoing laparoscopic surgery under general anesthesia:An Observational 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 |
Sayanta Das |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,All India Institute of
Medical Sciences (AIIMS), Marudhar Industrial Area Phase-II, Basni,
Jodhpur
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8944978902 |
| Fax |
|
| Email |
sayanta.2812das@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpa Goyal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,All India Institute of
Medical Sciences (AIIMS), Marudhar Industrial Area Phase-II, Basni,
Jodhpur
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996880 |
| Fax |
|
| Email |
drshilpagoyal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sayanta Das |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,All India Institute of
Medical Sciences (AIIMS), Marudhar Industrial Area Phase-II, Basni,
Jodhpur
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8944978902 |
| Fax |
|
| Email |
sayanta.2812das@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Basni Industrial Area Phase-II, Jodhpur,Rajasthan
(INDIA) 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS Jodhpur |
| Address |
Basni Industrial Area Phase II, Jodhpur, Rajasthan (INDIA) 342005 |
| Type of Sponsor |
Research institution and 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 |
| Dr Sayanta Das |
AIIMS JODHPUR |
Department of
Anaesthesiology and
Critical Care, 3rd Floor,
DnT Block, AIIMS,
Basni Industrial Area
Phase-II, Jodhpur-
342005
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
8944978902
sayanta.2812das@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients belonging to the group of ASA I/II and in the age group of 1-18 years scheduled to
undergo elective laparoscopic surgeries under general anaesthesia with duration less than 2 hours.
|
|
| ExclusionCriteria |
| Details |
1. Patients undergoing emergency surgeries.
2. Patients having preoperative hemodynamic instability.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare three criteria in terms of time taken for discharge from post anesthesia care unit in pediatric patients aged 1-18 years, undergoing elective laparoscopic surgeries under general anesthesia. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess:
1.Any complications during PACU stay.
2.Any complications noted in the ward till 24 hours after discharge from PACU.
3.Total opioid use in perioperative period.
4.Total antiemetic use in perioperative period.
|
At baseline |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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)
|
01/12/2024 |
| 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) |
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)
|
After receiving approval from the Institutional Ethical Committee and registration in CTRI, Children who satisfy the specified criteria will be chosen to take part in the study. Written and informed consent will be mandatory from the parents/guardians of patients who are taking part in the study. Assent will be acquired from children who are above the age of seven. A thorough preoperative assessment will be performed the day before the procedure. Younger children will get premedication consisting of Inj. Midazolam and Inj. Ketamine as per the Institutional protocol. The child will be administered IV Fentanyl and IV Propofol as per the Institutional protocol for induction. The initiation of neuromuscular paralysis will be achieved using either Inj. Atracurium or Inj. Rocuronium, based on the discretion of the overseeing anesthesiologist. The maintenance of anaesthesia will be accomplished by utilising a mixture of oxygen and sevoflurane. The reversal of the neuromuscular blockade will be accomplished with intravenous administration of Neostigmine and Glycopyrrolate. The child will be relocated to the Post-Anesthesia Care Unit (PACU). Every patient will be assessed for the time taken to discharge from the Post-Anesthesia Care Unit (PACU) using all the three scores. The time duration required to attain a score of ≥9 in the Modified Aldrete score, ≥9 in the Modified postanesthetic discharge score, and ≥12 in the White’s fast-track score will be documented. The quantity of opioids and antiemetics administered throughout the perioperative period will be documented. All adverse complications will be recorded in the Post-Anesthesia Care Unit (PACU) and 24 hours after being discharged from the PACU. |