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

Phase 2

Completed

• Conditions: Dexmedetomidine; Intratracheal
• Interventions: Drug: Saline Solution; Drug: Intratracheal dexmedetomidine

• Registration Number: NCT04385602
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2020-06-01
• Primary Completion: 2022-10-01
• Study Completion: 2023-01-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CON group	Saline Solution	placebo
DT group	Intratracheal dexmedetomidine	Intratracheal dexmedetomidine

Primary Outcome Measures

Name	Time	Method
the coughing severity	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.

Secondary Outcome Measures

Name	Time	Method
the Pediatric Objective Pain Scale	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

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt