Ketamin Plus Propofol for Anesthesia Induction

Phase 4

Completed

• Conditions: Postoperative Recovery
• Interventions: Drug: Ketamine

• Registration Number: NCT04761159
• Lead Sponsor: Cukurova University

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.

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 Timeline

• Study First Submitted: 2021-01-28
• Study Start: 2021-02-15
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Status Verified: 2022-01
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol	Ketamine	propofol 3 mg/kg will perform for anesthesia induction
Ketofol1/1	Ketamine	Propofol 1 mg/kg + ketamin1 mg/kg (1/1 ratio) for group I to anesthesia induction.
Ketofol1/2	Ketamine	propofol 1,5 mg/kg + ketamin 0,75 mg/kg (2/1 ratio) for group II to anesthesia induction
Ketofol1/3	Ketamine	propofol 2 mg/kg +ketamin 0,66 mg/kg (3/1 ratio) for group III to anesthesia induction

Primary Outcome Measures

Name	Time	Method
Delirium score	30 minutes in PACU	Watcha scores will record till the patient discharge from the PACU.

Secondary Outcome Measures

Name	Time	Method
length of stay in PACU	30 minutes in PACU	The participants will observe in PACU till the Aldrete score will achieve 15. This duration of time will record.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey