The Effect of Dexamethasone on Sugammadex Reversal

August 12, 2015 updated by: Ersel GULEC, Cukurova University

The Effect of Dexamethasone on Sugammadex Reversal in Pediatric Patients Undergoing Adenotonsillectomy: a Randomized, Placebo-controlled Study

The purpose of this study is to determine whether dexamethasone extends the duration of recovery from anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After obtaining Local Ethics Committee of Cukurova University approval and written parental consent, this prospective, randomized, double blind, placebo-controlled study will be performed. Sixty patients scheduled for elective tonsillectomy or adenoidectomy, aged 3-8 years with American Society of Anesthesiologists physical status 1 and 2 are recruited to the study. Exclusion criteria are the presence of respiratory, hepatic, renal and cardiovascular disease, oropharyngeal or facial pathology, neuromuscular disorder, hypertension and diabetes mellitus. Patients are randomly allocated into two groups in a 1:1 ratio by a computer-generated list. Allocation is provided with sealed envelopes containing group named paper.

Patients are admitted to the preoperative unit 30 minutes before the operation. All patients are monitored with non-invasive blood pressure (NIBP), electrocardiogram (ECG), end-tidal carbon dioxide (ETCO2) and peripheral oxygen saturation (SpO2) in the operating room before the start of anesthesia induction. Anesthesia is induced with 4-5 % sevoflurane and a cannula (18 gauges) is placed intravenously after ensuring adequate depth of anesthesia and thus 0.9% of saline infusion is started at a 10 mL kg-1 hr-1 rate for hydration. Patients are received dexamethasone via intravenous (iv) route of 0.5 mg.kg-1 (maximum dose of 15 mg) and an equal volume of saline iv, in group D and group S, respectively.

Neuromuscular monitoring is initiated after the induction of anesthesia by an acceleromyograph (TOF-Watch® S; Organon Ireland Ltd, Drynam Road, Swords, Co. Dublin, Ireland) measuring the function of adductor pollicis muscle. A transducer is attached over the thumb. Two electrodes are placed on cleaned skin corresponding to the ulnar nerve trajectory at the wrist. Stabilization and calibration are performed for TOF-Watch S according to good clinical research practice in pharmacodynamic studies of NMBAs. (Fuchs-Buder, Claudius et al. 2007) After calibration, Train of Four stimulations (TOF) are applied repetitively every 15 minutes for 3 minutes. Rocuronium is administered intravenously at a dose of 0.6 mg.kg-1 followed by calibration period. Tracheal intubation is performed after obtaining the adequate neuromuscular blockade. TOF stimulation is maintained every 15 minutes until the end of anesthesia, or until the TOF ratio is 0.9. SpO2, ECG and NIBP monitoring with 10 minutes intervals and neuromuscular data obtained by TOF-Watch® S are recorded. When the T2 of the TOF reappeared, all patients are administered a single bolus injection of sugammadex at a dose of 2 mg.kg-1. The time to achieve a TOF ratio of 0.9 after sugammadex administration is recorded for all patients.

At the end of surgery anesthesia is terminated and the awake patients are extubated. After extubation, patients are transported to the postoperative care unit. Pulse oximetry, respiratory rate and non-invasive blood pressure monitoring, the level of consciousness and clinical evaluation of recovery (5 s head lift test, absence of diplopia, tongue depressor test, and general muscle weakness) are recorded with 15 minutes intervals during 60 minutes in the postanesthesia care unit (PACU). Any adverse effects are recorded during the surgery and postoperatively for 10 hours. All records and drug administrations are performed by an anesthetist, who is blinded to the patient group. The primary endpoint is defined as the time to achieve TOF ratio to 0.9 after sugammadex administration.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01130
        • Cukurova University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for elective tonsillectomy or adenoidectomy,
  • aged 3-8 years
  • with American Society of Anesthesiologists physical status 1 and 2

Exclusion Criteria:

  • the presence of respiratory, hepatic, renal and cardiovascular disease,
  • oropharyngeal or facial pathology
  • neuromuscular disorder
  • hypertension
  • diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Patients are received dexamethasone via intravenous (iv) route of 0.5 mg.kg-1 (maximum dose of 8 mg) in group D at the induction of anesthesia.
Drug: Dexamethasone
dexamethasone administration, intravenously
Other Names:
  • Dekort
Placebo Comparator: Placebo
An equal volume of saline iv in group S at the induction of anesthesia.
Drug: Placebo
saline administration intravenously
Other Names:
  • Saline,0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is the time to achieve TOF (Train of Four stimulation) ratio to 0.9 after sugammadex administration.
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Ersel Gulec, M.D., Cukurova University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DXSX01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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