MedTrace Logo

Intrathecal Dexmedetomidine Versus Fentanyl With Bupivacaine in Children Undergoing Major Abdominal Cancer Surgery

NCT02861716 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-04-10

No results posted yet for this study

Summary

In this study the investigators aim to determine the analgesic effect and side effects of intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric patients undergoing major abdominal cancer surgeries.

Conditions

  • Intrathecal Dexmedetomidine
  • Pediatric Cancer Surgery

Interventions

DRUG

Bupivacaine

premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery. After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight in 2ml volume and it will be injected slowly over 20 seconds.

DRUG

Fentanyl

premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery. After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight plus fentanyl 0.2 μg/kg in 2ml volume and it will be injected slowly over 20 seconds.

DRUG

Dexmedetomidine

premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery. After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight plus dexmedetomidine 0.2 μg/kg in 2ml volume and it will be injected slowly over 20 seconds.

Sponsors & Collaborators

  • South Egypt Cancer Institute

    lead OTHER

Principal Investigators

  • rania abdelemam, lecturer · South Egypt Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-02-28
Completion
2019-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

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 NCT02861716 on ClinicalTrials.gov