NCT04761159

Brief Summary

ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery. Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III; propofol 3 mg/kg will perform for anesthesia induction. General anesthesia will maintenance with sevoflurane 1-2% and O2/N2O mixture. Morphine 0.1mg/kg IV will be apply for postoperative analgesia at 10 min of anesthesia. Extubation time, length of stay in PACU, Watcha score, FLACC score will record. Than all data will statistically analyse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

April 20, 2023

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

January 28, 2021

Last Update Submit

April 18, 2023

Conditions

Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

  • Delirium score

    Watcha scores will record till the patient discharge from the PACU.

    30 minutes in PACU

Secondary Outcomes (1)

  • length of stay in PACU

    30 minutes in PACU

Study Arms (4)

Ketofol1/1

ACTIVE COMPARATOR

Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I to anesthesia induction.

Drug: Ketamine

Ketofol1/2

ACTIVE COMPARATOR

propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II to anesthesia induction

Drug: Ketamine

Ketofol1/3

ACTIVE COMPARATOR

propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III to anesthesia induction

Drug: Ketamine

propofol

ACTIVE COMPARATOR

propofol 3 mg/kg will perform for anesthesia induction

Drug: Ketamine

Interventions

KetamineDRUG

Different mixture of ketamin-propofol will apply for anesthesia induction.

Also known as: ketofol
Ketofol1/1Ketofol1/2Ketofol1/3propofol

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II patients
  • Underwent adenoidectomy-tonsillectomy surgery
  • Age between 3-12

You may not qualify if:

  • ASA III-IV patients
  • Age; under 3 years old
  • Age; above 12 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01380, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised, controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 18, 2021

Study Start

February 15, 2021

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

April 20, 2023

Record last verified: 2022-01

Locations

TU(1)