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Emergence Agitation of Sevoflurane in Pediatric

NCT06830564 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-02-17

No results posted yet for this study

Summary

Low dose nalbuphine versus dexmedetomidine on prevention of emergence agitation in children

Conditions

  • Emergence Delirium

Interventions

DRUG

we will give the patient 0.1 mg nalbuphine 15 min before the end of the procedure

The study medications will be prepared by the local pharmacy as 10 ml syringes of nalbuphine IV that will be handled to the anesthesiologist in charge in OR room who will be blinded to the nature of the medications used, and study medications will be given 15 minutes before the end of surgical procedure and it will be given slowly for five minutes. . After extubation, patients will be taken to postanesthetic care unit . on arrival vital data will be measured. The anesthesiologist following up the patient will be blinded to the groups. The time of extubation will be defined as zero and after 15 minutes will be defined as one . Assessment of agitation will be done at time zero and time 1 and every fifteen minutes for 30 minutes using paediatric anaesthesia Emergence delirium scale (PAEDS)

DRUG

we will give the patient 0.5 mg dexmedetomidine 15 min before the end of the procedure

The study medications will be prepared by the local pharmacy as 10 ml syringes of dexmedetomidine IV that will be handled to the anesthesiologist in charge in OR room who will be blinded to the nature of the medications used, and study medications will be given 15 minutes before the end of surgical procedure and it will be given slowly for five minutes. . After extubation, patients will be taken to postanesthetic care unit . on arrival vital data will be measured. The anesthesiologist following up the patient will be blinded to the groups. The time of extubation will be defined as zero and after 15 minutes will be defined as one . Assessment of agitation will be done at time zero and time 1 and every fifteen minutes for 30 minutes using pediatric anesthesia Emergence delirium scale (PAEDS) .

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Madlin A selwanes, M.B.B.CH · anesthesia resident at Ain shames university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830564 on ClinicalTrials.gov