Anesthesia for Retinopathy of Prematurity

NCT01955135 | Completed Phase 4

• 1 other identifier: 2010 /145
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Premature infants experience more respiratory problems after surgical procedures. The investigators aimed to compare general anesthesia with sedation on the need for post-operative mechanical ventilation in infants undergoing retinopathy of prematurity surgery.

Conditions

Retinopathy

Keywords

Prematurity, Retinopathy, propofol, ketamine, sedation

Outcome Measures

Primary Outcomes (1)

• Respiratory failure after retinopathy of prematurity surgery in premature infants.

  Most of premature infants have chronic lung disease, for this reason endotracheal intubation causes some problems, because they have irritable airway. Administration of sedation and avoiding endotracheal intubation can be better for postsurgical outcomes. How many infants needed endotracheal intubation and mechanical ventilation were recorded.

  1 Day (From end of anaesthesia till discharge from the recovery room )

Secondary Outcomes (2)

• Blood Pressure

  1 Day (From start of anaesthesia till discharge from the operation room)

• Heart rate

  1 Day (From start of anaesthesia till discharge from the recovery room )

Study Arms (2)

sedation

ACTIVE COMPARATOR

The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance.

Drug: Ketamine; Drug: propofol

general anesthesia

ACTIVE COMPARATOR

In the general anesthesia group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen.

Drug: Sevoflurane

Interventions

Ketamine DRUG

1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation

Also known as: ketalar, 50mg/ml

sedation

Sevoflurane DRUG

anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen

Also known as: sevorein

general anesthesia

propofol DRUG

1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol

Also known as: pofol

sedation

Eligibility Criteria

• Age: 32 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of ROP

You may not qualify if:

• the need for mechanical ventilation or intubation in the 3 days prior to the operation,
• known allergy or hypersensitivity reaction to ketamine and propofol,
• age ˃40 weeks.

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Retinal Diseases; Premature Birth

Interventions

Ketamine; Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Eye Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• AYŞE ÜLGEY, MD

  TC Erciyes University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: October 7, 2013
• Study Start: September 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 7, 2013

Record last verified: 2013-09