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

NCT02602743 | Completed Phase 4

• 1 other identifier: PRK01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sedation; remifentanyl; pediatric patient; colonoscopy

Outcome Measures

Primary Outcomes (1)

• Ketamine, remifentanyl, propofol consumption

  The amount of anesthetic used during colonoscopy will be recorded as milligram/kilogram for each patient.

  1 hour

Secondary Outcomes (3)

• Blood pressure

  1 hour

• Hypoxia

  1 hour

• Heart rate

  1 hour

Study Arms (2)

remifentanyl, ketamine

EXPERIMENTAL

Experimental:Remifentanyl and ketamine Remifentanyl vial 2 mg, Ketamine vial 500mg/10 mlt by intravenous. 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.

Drug: Remifentanyl; Drug: Ketamine

propofol, ketamine

ACTIVE COMPARATOR

Active comparator:Propofol and ketamine Propofol injectable emulsion vial 200 mg/20 mlt, Ketamine vial 500mg/10 mlt by intravenous. 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.

Drug: Propofol; Drug: Ketamine

Interventions

Remifentanyl DRUG

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

Also known as: Ultiva

remifentanyl, ketamine

Propofol DRUG

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

Also known as: Pofol

propofol, ketamine

Ketamine DRUG

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

Also known as: Ketalar

propofol, ketamine; remifentanyl, ketamine

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA I-II
• years old children

You may not qualify if:

• Children with cardiovascular disease,
• Children with cerebral disorder, respiratory disease,
• Children with renal failure
• Children with hepatic failure

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Medicine Research Hospital

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Remifentanil; Propofol; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• Dilek Özcengiz, Prof

  Cukurova University

  STUDY CHAIR

• Çağatay Küçükbingöz, Asistant dr

  Cukurova University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 11, 2015
• Study Start: August 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)