Effect of Intratracheal Dexmedetomidine Administration on Recovery From General Anesthesia in Pediatrics Undergoing Lower Abdominal Surgery:

June 12, 2023 updated by: Ghada Mohammed AboelFadl, Assiut University

Effect of Administration of Intratracheal Dexmedetomidine on Recovery From General Anesthesia in Pediatrics Undergoing Lower Abdominal Surgery: a Randomized Double-blinded Controlled Study.

The incidence of intratracheal tube-induced laryngeal irritation, including coughing, bucking, and cardiovascular stimulation, on emergence from general anesthesia has been reported to occur in 38% and 96% of cases. This may cause agitation and unstable hemodynamics during anesthesia recovery, and can lead to complications, such as laryngeal edema, sore throat, increased intra-abdominal pressure, and anastomotic bleeding. Accordingly, many anesthesiologists have been seeking methods through which such laryngeal irritation can be attenuated, thus allowing for a smoother extubation. Furthermore, it has contributed to the aggravation of cough reflexes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several strategies have been reported to facilitate smoother extubation, such as intravenous lidocaine, remifentanil, and dexmedetomidine. Dexmedetomidine is a potent, alpha-2-selective adrenoceptor agonist that causes sympatholytic, sedation and analgesia without respiratory compromise. The sedative properties of dexmedetomidine are largely due to effects on the locus ceruleus, producing a level of consciousness mimicking natural sleep Delivering dexmedetomidine intravenously to attenuate airway and circulatory reflexes during extubation has been extensively evaluated in clinical studies. Recent studies have also indicated that the intranasal application of dexmedetomidine is significantly useful and effective in the achievement of improved sedation and analgesia) and offers a safety profile similar to traditional sedatives ( ketamine and midazolam). Additionally, intratracheal local anesthetic instillation has been reported to be effective in preventing laryngeal reflexes. However, both the efficacy and safety profile of intratracheal dexmedetomidine applications are largely unknown and the technique has not been specifically investigated.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

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

  • Egypt
      • Assiut, Egypt
        • Assiut governorate

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

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA physical status classification I-II.
  • Scheduled for lower abdominal surgeries e.g. congenital hernia repair and correction of penile hypospadias under general anesthesia (GA).

Exclusion Criteria:

  • Younger than 1 year and older than 6 years of age,
  • ASA score of III to IV.
  • Parental refusal
  • Allergy or contraindication to studied medication or anesthetic agents
  • Patients with respiratory disease, heart disorders which might represent risk factors of potential complications of Dexmedetomidine such as bradycardia, hepatic or renal insufficiency.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CON group
placebo
Drug: Saline Solution
Thirty minutes before the end of the surgery, 1ml saline in a medical spray bottle will be sprayed down the intratracheal tube
Active Comparator: DT group
Intratracheal dexmedetomidine
Drug: Intratracheal dexmedetomidine
Thirty minutes before the end of the surgery, Dex (0.5μg/kg diluted and mixed in 1ml saline in a medical spray bottle) will be sprayed down the intratracheal tube
Other Names:
  • precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the coughing severity
Time Frame: intraoperative (during the recovery period from the time of awareness to 5 min after extubation)

judged by the 4-point scale. 0 = no cough, 1= minimal (single) cough, 2 = moderate (≤5 ) cough and 3= severe (>5 ) cough.

Grades 2 and 3 were bad.
intraoperative (during the recovery period from the time of awareness to 5 min after extubation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Pediatric Objective Pain Scale
Time Frame: 24 hours postoperative

monitor pain in children after surgery.• Minimum score: 0

  • Maximum score: 10
  • Maximum score if too young to complain of pain: 8
  • The higher the score the greater the degree of pain
24 hours postoperative

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Actual)

June 1, 2020

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intratracheal dexmed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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