Ketamin Plus Propofol for Anesthesia Induction

NCT ID: NCT04761159

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-12-15

Brief Summary

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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

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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.

Conditions

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Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ketofol1/1

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Ketofol1/2

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Ketofol1/3

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

propofol

propofol 3 mg/kg will perform for anesthesia induction

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Interventions

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Ketamine

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

Intervention Type DRUG

Other Intervention Names

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ketofol

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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ebru biricik

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova University

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Ketamin-propofol

Identifier Type: -

Identifier Source: org_study_id

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