N/A
N=142
A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
Adult Intracranial Tumor · Adult Solid Tumor
Bottom Line
View on ClinicalTrials.gov: NCT01269918 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Hemodynamics — 98; 88 mmHg — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remifentanil (Drug); Dexmedetomidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemodynamics |
98; 88 | < 0.001 sig |
| PRIMARY Postoperative Pain |
5.1; 2.9 | < 0.001 sig |
| PRIMARY Total Opioid Consumption |
10; 5 | < 0.001 sig |
| SECONDARY Heart Rate |
76; 68; 72; 67; 73; 66 | < 0.001 sig |
| SECONDARY Modified Short Orientation Memory Concentration Test (SOMCT) |
22; 18; 25; 20; 25; 23 | 0.16 |
| SECONDARY Aldrete Score |
8.4; 8; 8.7; 8.3; 9.0; 8.7 | 0.07 |
| SECONDARY Nursing Workload Comparison |
6; 5.5 | 0.009 sig |
| SECONDARY Drug Stop Time to Open Eyes |
8; 38 | < 0.001 sig |
| SECONDARY Drug Stop Time to Recall |
13; 42 | < 0.001 sig |
| SECONDARY Drug Stop Time to Fitness to Discharge |
150; 172 | 0.022 sig |
| SECONDARY End Case to Post Anesthesia Care Unit (PACU) Discharge |
211; 215 | 0.45 |
| SECONDARY Postoperative Nausea |
12; 12 | 0.91 |
| SECONDARY Postoperative Vomitting |
6; 2 | 0.16 |
| SECONDARY Postoperative Shivering |
7; 3 | 0.21 |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
- Patient refusal
- Emergency craniotomy
- Morbid obesity
- Uncontrolled hypertension - DBP more than 110
- Cardiac conduction defects
- Patients with chronic pain.
Data sourced from ClinicalTrials.gov (NCT01269918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.