Remifentanil Use in Pediatric Rigid Bronchoscopy

NCT01947114 | Completed Phase 4

• 1 other identifier: CTF.08.11.05/31128
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: In this study we wanted to compare bolus propofol and ketamine as an adjuvant to remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy. Materials and Methods: Forty children under 12 years of age scheduled for rigid bronchoscopy were included. After midazolam premedication, remifentanil infusion 1 µg/kg/min was started and patients were randomly allocated to receive either propofol (Group P) or ketamine (Group K) and mivacurium for muscle relaxation. Anesthesia was maintained with remifentanil infusion 1 µg/kg/min and bolus doses of propofol or ketamine. After rigid bronchoscopy remifentanil 0.05 µg/kg/min was maintained until extubation. Hemodynamic parameters, emergence characteristics and adverse events were evaluated.

Conditions

Pediatric Rigid Bronchoscopy

Keywords

General anesthesia,; Children,; Rigid Bronchoscopy,; Remifentanil,; Propofol,; Ketamine.

Outcome Measures

Primary Outcomes (1)

• Change in systolic arterial pressure

  Noninvasive systolic blood pressure was measured with 3 minutes of interval during rigid bronchoscopy. The duration of rigid bronchoscopy was 10-15 minutes.

  Systolic arterial pressure was assessed before anesthesia induction (baseline), 2 minutes after anesthesia induction, at 1., 3., 6., 9., 12., and 15. minutes of rigid bronchoscopy.

Study Arms (2)

Group Propofol

ACTIVE COMPARATOR

Drug: Propofol; Drug: Remifentanil

Group Ketamine

ACTIVE COMPARATOR

Drug: Ketamine; Drug: Remifentanil

Interventions

Propofol DRUG

Group Propofol

Ketamine DRUG

Group Ketamine

Remifentanil DRUG

Group Ketamine; Group Propofol

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who were scheduled to have rigid bronchoscopy for diagnostic purposes (suspected foreign body aspiration, bronchoalveolar lavage)
• Children who were scheduled to have rigid bronchoscopy for therapeutic purposes (removal of foreign bodies and/or mucus plugs)

You may not qualify if:

• Severe cardiovascular disease
• Cerebral, hepatic or renal dysfunction
• Neuromuscular disease
• Children with predicted difficulty in laryngoscopy and intubation
• Patients requiring prompt interventions for a life-threatening situation (acutely compromised airway with SpO2 values below 70%)
• Patients scheduled for additional interventions or surgery subsequent to rigid bronchoscopy

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Propofol; Ketamine; Remifentanil

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 20, 2013
• Study Start: November 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: September 20, 2013

Record last verified: 2013-09

Locations

TU (1)