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Propofol-Ketamine vs Remifentanyl-Ketamine for Sedation in Pediatric Patients Undergoing Colonoscopy

NCT02602743 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-02-06

No results posted yet for this study

Summary

Ketamine and propofol have been used most frequently agents and remifentanil is used with increasing frequency in recent years. Investigators will compare ketamine-propofol and ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in pediatric colonoscopy patients. Our study is a prospective, randomized comparison of ketamine-propofol and remifentanyl-propofol for sedation in pediatric patients during elective colonoscopy. ASA I-II, 2-16 years old, seventy children will be included in the study after ethics committee approval and written informed consent from the parents. Children with cardiovascular, cerebral, pulmonary, renal and hepatic diseases will be excluded from the study. Group I (RK); 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be administered for induction in 1 minute.Then 0,1 µg/kg/h remifentanyl infusion will be started.

Group II (PK); 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started. In case of movement, crying, heart rate and systolic blood pressure more than 20% increase from baseline; 0.05 to 0.1 mg / kg of remifentanil will be administered in group I, 0.5-1 mg / kg will be administered propofol in group II. Not enough that case 0.5-1 mg / kg of ketamine will be applied.

The anesthesiologist will continue monitoring after completion of colonoscopy until recovery of full consciousness. A Steward recovery score of 7 will be defined as the end of the recovery time.

Conditions

  • Delayed Emergence From Anesthesia

Interventions

DRUG

Remifentanyl

0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.

DRUG

Propofol

1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.

DRUG

Ketamine

2 mg/kg ketamine will be administered for induction in 1 minute.

Sponsors & Collaborators

  • Cukurova University

    lead OTHER

Principal Investigators

  • Dilek Özcengiz, Prof · Cukurova University

  • Çağatay Küçükbingöz, Asistant dr · Cukurova University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02602743 on ClinicalTrials.gov