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Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioids in Cleft Palate Repaire

NCT05402189 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-06-02

No results posted yet for this study

Summary

This study will be conducted to compare Ketodex versus opioid based anaesthesia in cleft palate repair surgeries .

Conditions

  • Ketodex Versus Opioids Based Anaesthesia in Cleft Palate Repair

Interventions

DRUG

Ketodex, Fentanyl

The patients will be randomized into 2 groups : group (KD) and group (OP) . Two 20 ml syringes, labelled loading and another two 20 ml syringes labelled maintenance will be given to each patient according to his group. Group (KD): patients will receive 1mg/kg ketamine and 1ug/kg dexmiditomidine in their respective loading syringes diluted in 20ml normal saline. Then , they will receive ketamine 0.1 mg/kg /hr and dexmedetomidine0.2ug/kg/hr in their maintenance syringes prepared in 20 ml normal saline in a concentration of 1mg/ml ketamine and 1ug/ml dexmiditomidine respectively . Group (OP): one of the loading syringes will contain fentanyl in a dose of 2ug/kg diluted in 20 ml normal saline and the other loading syringe will contain normal saline. Then, the patients will receive 0.5ug/kg/hr fentanyl through one of the maintenance syringes while the other syringe contains normal saline.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-06-10
Completion
2022-06-20

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 NCT05402189 on ClinicalTrials.gov