NCT04385602

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

May 9, 2020

Last Update Submit

June 12, 2023

Conditions

IntratrachealDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • the coughing severity

    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 Outcomes (1)

  • the Pediatric Objective Pain Scale

    24 hours postoperative

Study Arms (2)

CON group

PLACEBO COMPARATOR

placebo

Drug: Saline Solution

DT group

ACTIVE COMPARATOR

Intratracheal dexmedetomidine

Drug: Intratracheal dexmedetomidine

Interventions

Intratracheal dexmedetomidineDRUG

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

Also known as: precedex
DT group
Saline SolutionDRUG

Thirty minutes before the end of the surgery, 1ml saline in a medical spray bottle will be sprayed down the intratracheal tube

CON group

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

Related Publications (3)

  • Fan Q, Hu C, Ye M, Shen X. Dexmedetomidine for tracheal extubation in deeply anesthetized adult patients after otologic surgery: a comparison with remifentanil. BMC Anesthesiol. 2015 Jul 23;15:106. doi: 10.1186/s12871-015-0088-7.

    PMID: 26202786BACKGROUND

  • Bhattacharjee DP, Saha S, Paul S, Roychowdhary S, Mondal S, Paul S. A comparative study of esmolol and dexmedetomidine on hemodynamic responses to carbon dioxide pneumoperitoneum during laparoscopic surgery. Anesth Essays Res. 2016 Sep-Dec;10(3):580-584. doi: 10.4103/0259-1162.183564.

    PMID: 27746555BACKGROUND

  • Kim H, Min KT, Lee JR, Ha SH, Lee WK, Seo JH, Choi SH. Comparison of Dexmedetomidine and Remifentanil on Airway Reflex and Hemodynamic Changes during Recovery after Craniotomy. Yonsei Med J. 2016 Jul;57(4):980-6. doi: 10.3349/ymj.2016.57.4.980.

    PMID: 27189295BACKGROUND

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 13, 2020

Study Start

June 1, 2020

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

EG(1)