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

NCT ID: NCT04385602

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-01-01

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.

Conditions

Intratracheal; Dexmedetomidine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CON group

placebo

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

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

DT group

Intratracheal dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Intratracheal dexmedetomidine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

precedex

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut governorate

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 26202786 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27746555 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27189295 (View on PubMed)

Other Identifiers

intratracheal dexmed

Identifier Type: -

Identifier Source: org_study_id