Ketamin Plus Propofol for Anesthesia Induction

Postoperative Recovery Clinical Trial

Official title:

Effect of Ketamin+Propofol Mixture on Postoperative Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761159
• Other study ID #: Ketamin-propofol
• Status: Completed
• Phase: Phase 4
• Start date: February 15, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2022
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Recovery

Intervention

Drug:
• Ketamine
Different mixture of ketamin-propofol will apply for anesthesia induction.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium score	Watcha scores will record till the patient discharge from the PACU.	30 minutes in PACU
Secondary	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