Ketamin Plus Propofol for Anesthesia Induction

Effect of Ketamin+Propofol Mixture on Postoperative Recovery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Recovery
• Intervention / Treatment: Drug: Ketamine

Detailed Description

ASA I-II 112 pediatric patients will recruit who underwent adenoidectomy-tonsillectomy surgery in this randomised controlled study. The participants will divide into the 4 groups with computered random generation. The Different combination of propofol+ketamin mixture will apply at the induction of anesthesia. The groups will assign as group I,II, III and IV. 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. Fentanyl 1 microgram per kg and rocuronium 0.6 mg/kg will apply for anesthesia induction to the all participants. 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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01380
    • Cukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketofol1/1; Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I to anesthesia induction.	Drug: Ketamine; Different mixture of ketamin-propofol will apply for anesthesia induction.; Other Names: ketofol
Active Comparator: Ketofol1/2; propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II to anesthesia induction	Drug: Ketamine; Different mixture of ketamin-propofol will apply for anesthesia induction.; Other Names: ketofol
Active Comparator: Ketofol1/3; propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III to anesthesia induction	Drug: Ketamine; Different mixture of ketamin-propofol will apply for anesthesia induction.; Other Names: ketofol
Active Comparator: propofol; propofol 3 mg/kg will perform for anesthesia induction	Drug: Ketamine; Different mixture of ketamin-propofol will apply for anesthesia induction.; Other Names: ketofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium score	Watcha scores will record till the patient discharge from the PACU.	30 minutes in PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay in PACU	The participants will observe in PACU till the Aldrete score will achieve 15. This duration of time will record.	30 minutes in PACU

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: Ketamin-propofol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No