A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain

NCT01269918 | Completed Results DMC

• 1 other identifier: 10-1056
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

This will be a randomized blinded clinical trial. Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team will know the result of randomization at induction. Data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.

Conditions

Adult Intracranial Tumor; Adult Solid Tumor

Keywords

Craniotomy, pain relief; Adult solid neoplasm

Outcome Measures

Primary Outcomes (3)

• Hemodynamics

  Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.

  15, 30, 45, 60, and 90 minutes after extubation.

• Postoperative Pain

  Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.

  15, 30, 45, 60, and 90 minutes after extubation.

• Total Opioid Consumption

  Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.

  Initial 90 minutes of recover after surgery

Secondary Outcomes (11)

• Heart Rate

  15, 30, 45, 60, and 90 minutes after extubation.

• Modified Short Orientation Memory Concentration Test (SOMCT)

  15, 30, 45, 60, and 90 minutes after extubation.

• Aldrete Score

  15, 30, 45, 60, and 90 minutes after extubation.

• Nursing Workload Comparison

  90 minutes after extubation

• Drug Stop Time to Open Eyes

  Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Drug: Remifentanil

Dexmedetomidine

ACTIVE COMPARATOR

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Drug: Dexmedetomidine

Interventions

Remifentanil DRUG

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Also known as: Ultiva, G187084B

Remifentanil

Dexmedetomidine DRUG

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Also known as: Precedex, Dexmedetomidine Hydrochloride

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:
• Age: Older than 18
• Primary and redo cases will be included
• Duration of surgery not exceeding 6 hrs.

You may not qualify if:

• Patient refusal
• Emergency craniotomy
• Morbid obesity
• Uncontrolled hypertension - DBP more than 110
• Cardiac conduction defects
• Patients with chronic pain.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Remifentanil; Dexmedetomidine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Results Point of Contact

• Title: Daniel Sessler, MD
• Organization: Cleveland Clinic

sesslerd@ccf.org

216-445-6500

Study Officials

• Shobana Rajan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: January 4, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 20, 2016
• Results First Posted: December 20, 2016

Record last verified: 2016-10

Locations

US (2)