Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery

NCT ID: NCT05766436

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-09-30

Brief Summary

The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.

Detailed Description

All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be recorded. According to randomization that will be done by envelop concealed allocation , the drug will be administered to the patients by a researcher who will not participate in the evaluation of the patients 30 mins before transfer to the operation room (OR): each group will receive the intervention drug Parents are not allowed to accompany their children to the OR according to the hospital policy. On arrival to the OR department the Parental separation anxiety scale (PSAS) will be calculated on entering the operation room standard monitoring will be commenced including ECG, non-invasive blood pressure and pulse oximetry and baseline measurement will be recorded. Inhalational induction will be then started with sevoflurane and mask acceptance will be calculated according to the mask acceptance scale (MAS) intravenous cannulation will be then established after which each patient will receive 1-2 mg/kg Propofol, 1 µg/kg fentanyl to attenuate the stress of intubation and 0.5mg/kg atracurium after tracheal intubation anesthesia will be maintained with sevoflurane 2-4 MAC During the length of the operation vital data will be recorded at 5 minutes interval. all patients will receive IV paracetamol 15mg/kg and patient would receive 1 µg/kg fentanyl as a rescue dose if vital data increased by >20% of the baseline.

after the completion of surgery extubating will be performed after meeting extubation criteria and patient will be discharged to post-anesthesia care unit (PACU) in for the first 15 min after admission to PACU the post anesthesia emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) during the stay in PACU pain will also be assessed by using FLACC score Discharge from PACU will be done after meeting discharge criteria and the time of discharge will be documented. After discharge pain score will be measured using FLACC score at 15, 30, 60 minutes interval postoperative and the total combustion of postoperative analgesics will be calculated as well as the time of discharge from the hospital

Conditions

Anxiety Acute; Emergence Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group D

will receive placebo ODF and nebulized dexmedetomidine (Precedex™ rxlist)

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

receive placebo ODF and 3 µ/kg nebulized dexmedetomidine (Precedex™ rxlist) prepared in 0.9% normal saline to a final volume of 3ml. Nebulization was performed using a wall nebulizer and wall oxygen source on 4 l/min.

group M

will receive placebo nebulizer and ODF melatonin (metacyst ™ nerhadou)

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

will receive placebo nebulizer and 0.4mg/kg of ODF melatonin (metacyst ™ nerhadou) orally allowing the film to dissolve in the patients Oro mucosal lining

group C

will receive placebo ODF and placebo 0.9% normal saline nebulizer

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo ODF and 0.9% normal saline nebulizer

Interventions

Dexmedetomidine

receive placebo ODF and 3 µ/kg nebulized dexmedetomidine (Precedex™ rxlist) prepared in 0.9% normal saline to a final volume of 3ml. Nebulization was performed using a wall nebulizer and wall oxygen source on 4 l/min.

Intervention Type: DRUG

Melatonin

will receive placebo nebulizer and 0.4mg/kg of ODF melatonin (metacyst ™ nerhadou) orally allowing the film to dissolve in the patients Oro mucosal lining

Intervention Type: DRUG

Placebo

placebo ODF and 0.9% normal saline nebulizer

Intervention Type: DRUG

Other Intervention Names

Precedex™ rxlist; metacyst ™ nerhadou; normal saline

Eligibility Criteria

Inclusion Criteria

• Patients of American Society of Anesthesiologists (ASA) physical status I & II
• both genders,
• ≥ 2 to 10 years,
• scheduled for elective day case surgery under general anesthesia

Exclusion Criteria

• parents' refusal for participation in the study
• ASA III and VI patients with history of chronic illness
• runny nose or upper respiratory tract infection
• Emergency surgeries with hemodynamic instability
• history of allergic reaction to dexmedetomidine or melatonin
• History of prematurity
• developmental delay
• central nervous system disorder,
• mental retardation,
• neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.).
• treatment with anticonvulsants and sedatives

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

nada moahmed aboelrouse

OTHER

Sponsor Role: lead

Responsible Party

nada moahmed aboelrouse

assistant lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sohair Abbas, MD

Role: STUDY_CHAIR

Ain Shams University, Anesthesia department

Ramy Mahrose, MD

Role: STUDY_DIRECTOR

Ain Shams University, Anesthesia department

Wessam Zaher, MD

Role: STUDY_DIRECTOR

Ain Shams University, Anesthesia department

Locations

Ain shams university hospital

Cairo, Abbasia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nada M Aboelrouse, masters

Role: CONTACT

nadaaboelrouse21@gmail.com

00201003371346

Mohamed A Tolba, MD

Role: CONTACT

Mohamedtolba@med.asu.edu.eg

0020115 6622298

Facility Contacts

Nada M Aboelrouse, masters

Role: primary

nadaaboelrouse21@gmail.com

00201003371346

mohamed A Tolba, MD

Role: backup

Mohamedtolba@med.asu.edu.eg

01156622298

Other Identifiers

FWA 000017585

Identifier Type: -

Identifier Source: org_study_id