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The Effect of Dexmedetomidine on Oxygen During One Lung Ventilation in Pediatric Surgery.

NCT04932746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-02-17

No results posted yet for this study

Summary

The children who will undergo OLV (one lung ventilation) through general anesthesia will be divided into two groups:

The first will be intravenous infusion of dexmedetomidine at 0.4 mcg / kg / hour, and the second will be intravenous infusion of normal saline.

We will take three samples of arterial blood gas (ABG) during the surgery at certain times. We record the hemodynamic values, PaO2, and calculate the value of the shunt Qs / Qt.

Conditions

  • One Lung Ventilation OLV
  • Esophageal Atresia
  • Hydrocystoma
  • Pneumonectomy
  • Pleura; Abscess

Interventions

DRUG

Dexmedetomidine

Infusion syringes are supplied with a concentration of 0.25 mcg / mL (dexmedetomidine or placebo) either 80 mcg / 20 mL, 200 mcg / 50 mL, or 400 mcg / 100 mL. It begins with infusion of 4 ml within 10 minutes and then continues infusion, depending on the child's weight, at 1.6 ml / kg / h. All injections will be prepared randomly by a doctor who did not participate in the study, and then placed in unmarked infusion pumps, given to an anesthesiologist (more than 10 years experience in pediatric anesthesia) without knowledge of the infusion content. The randomization process is carried out via sealed envelope technique. The injections in both groups will be stopped before the skin is closed. Both patients and anesthesiologists blinded the study drug (dexmedetomidine or placebo) by infusion of solution (dexmedetomidine or placebo). Depending on the size in ml, to ensure that there is no bias and blindness to the medical team about what the drug is.

DRUG

Placebo

The same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol

Sponsors & Collaborators

  • University Children's Hospital

    collaborator OTHER

  • Damascus University

    lead OTHER

Principal Investigators

  • Faten Rostom, PHD · Head of the Department of Anesthesiology Al-Assad University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • Syria

Study Locations

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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 NCT04932746 on ClinicalTrials.gov