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

Assiut University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Intratracheal

Dexmedetomidine

Treatments

Drug: Intratracheal dexmedetomidine

Drug: Saline Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT04385602

intratracheal dexmed

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

1 to 6 years old

Volunteers

No Healthy Volunteers

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.