Dexmedetomidine Infusion on Intraoperative Propofol,Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients

NCT05493228 | Unknown Phase 3

• 1 other identifier: CCHE-BT005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to investigate whether the effect of a low-dose dexmedetomidine infusion will decrease propofol consumption or not through a double blinded randomized controlled trial done in children cancer hospital 57357.

Conditions

Spine Cancer; Anesthesia

Outcome Measures

Primary Outcomes (4)

• Rate of propofol infusion per hour

  measured by infusion pump in ml/hr

  during surgery

• Change in MEP amplitude and latency

  intraoperatively monitoring by neurophysiology in MV

  at baseline and during surgery

• Depth of anesthesia by bispectral index

  intraoperatively by anesthesiologist BIS within normal range 40-60

  during surgery

• change in SSEP amplitude and latency

  intraoperatively monitoring by neurophysiology in MV

  at baseline and during surgery

Secondary Outcomes (3)

• to access rapid recovery in both arms

  immediately after surgery

• to access the event of hypotension in both arms

  baseline ,during surgery and immediately after surgery

• to access the event of bradycardia in both arms

  baseline, during surgery and immediately after surgery

Study Arms (2)

patient is receiving dexmedetomidine

EXPERIMENTAL

dexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose

Drug: Precedex Injectable Product

standard treatment (saline)

PLACEBO COMPARATOR

saline injection only after the induction of general anesthesia

Drug: Saline

Interventions

Precedex Injectable Product DRUG

Precedex activates 2-adrenoceptors, and causes the decrease of sympathetic tone, with attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery; it reduces anesthetic and opioid requirements; and causes sedation and analgesia. it is used before and/or during surgical

Also known as: dexmedetomidine

patient is receiving dexmedetomidine

Saline DRUG

mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl

Also known as: Salt water

standard treatment (saline)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• spinal cord tumor resection based on magnetic resonance imaging (MRI) studies.
• age between 5 -18 years old
• American Society of Anesthesiologists (ASA) physical status II or III.

You may not qualify if:

• Emergency spine surgery
• Cardiac patients
• Any individual with stage 4 or greater chronic kidney disease (eGFR\< 30 ml/min) and/or requiring dialysis
• liver failure defined as a history of cirrhosis or fulminant hepatic failure
• Preoperative dexmethatodine use
• Preoperative systolic hypertension defined by a systolic blood pressure greater than 130 mmHg in the surgical admission suite
• Enrolled in another study within 30 days.

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (1)

Children's Cancer Hospital Egypt 57357 Cairo, Egypt

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Dexmedetomidine; Sodium Chloride; Fluoridation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Study Officials

• suzan m Adlan, MD

  57357 children cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dina M elgalaly, Bph

CONTACT

01154021119; delgalaly@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The PI (anesthesiologist), neurosurgeon ,patient, all assisting surgeons and anesthesiologist as well operating and circulating nurse will be blinded to the study arm to which patient belongs to. Only clinical trial unit and pharmacist will be unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, double-blinded clinical trial will be done on all included cases. They will be divided into two groups after induction of general anathesia using propofolwhich will be started at 100 ug/kg/min) and titrated to maintain the bispectral index at 40-60 and fentanyl will be started at 0.5ug/kg/min) and to be adjusted as needed to control the hemodynamic response to the surgical procedure and maintain the mean arterial pressure (MAP) at 55-65 mmHg. Then will randomly divided using Block Stratified Randomized Software program, after obtaining informed consent from eligible patient or his caregiver into two Arms: Arm A: will receive dexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose which is colorless solution. Arm B :will receive placebo (saline injection) only after the induction of general anesthesia

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 9, 2022
• Study Start: May 17, 2022
• Primary Completion: April 17, 2023
• Study Completion: October 30, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-06

Locations

EG (1)