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OpenTrials
Completed

NCT Number: NCT04761159

Ketamin Plus Propofol for Anesthesia Induction

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.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cukurova University

Adana, 01380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

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

Other names: ketofol

Primary outcomes

  1. Delirium score

    Time frame: 30 minutes in PACU

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

Secondary outcomes

  1. length of stay in PACU

    Time frame: 30 minutes in PACU

    The participants will observe in PACU till the Aldrete score will achieve 15. This duration of time will record.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Effect of Ketamin+Propofol Mixture on Postoperative Recovery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2021
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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