Hemodynamic Instability, Supratentorial Neoplasms
Conditions
Keywords
Postoperative analgesia, Craniotomy, Dexmedetomidine
Brief summary
There is no clear consensus among neuroanesthesiologists regarding which anesthetic regimen is optimal for craniotomy. Propofol and short-acting opioids (such as remifentanil, fentanyl, or sufentanil) are commonly used. However, use of opioids is associated with increased risk of respiratory depression and postoperative nausea and vomiting. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been considered as a useful and safe adjunct to anesthesia for various surgical procedures
Detailed description
The investigators designed this randomized, double-blind study to evaluate the effectiveness of administration of Dexmedetomidine infusion at a dose of 0.5 µg/kg/h without loading dose during elective supratentorial craniotomy under GA. The investigators will compare intraoperative hemodynamics in both groups, intraoperative analgesic consumption, intraoperative blood loss, postoperative sedation scores, intraoperative need for rescue hypotensive agents, and finally the satisfaction of surgeons. To our knowledge, the present study is the first to evaluate the effect of Dexmedetomidine infusion without loading dose in elective supratentorial craniotomy
Interventions
DRUGDexmedetomidine
On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data. Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline Group C: Patients received equal volume and rate of normal saline as Group D. This dosing regimen was in accordance with existing guidelines \[5\] \[6\] \[7\].
DRUGnormal saline
On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data. Group C: Patients received equal volume and rate of normal saline as Group D.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* American society of anesthesiologists- Physical status (ASA-PS) I and II patients, * aged 18 to 65 years * 70-80 kg * both sexes * undergoing elective supratentorial craniotomy for tumor resection
Exclusion criteria
* Patients under 18 years of age * pregnancy, * emergency surgery * patients with a Glasgow Coma Score (GCS) less than 15. * Those who had respiratory or cardiac dysfunction, renal insufficiency, liver impairment, or bleeding disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean areterial blood pressure | 4 to 8 hours | incidence of intraoperative hemodynamic stability |
| Heart rate | 4 to 8 hours | incidence of intraoperative hemodynamic stability |
| Number of Participants needed rescue agents | 4 to 8 hours | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery time in minutes | At the end of operation | Recovery time in minutes (time interval between discontinuation of isoflurane and extubation). |
| Postoperative sedation level | 1st 2 hours postoperatively | Assessment of postoperative sedation level using University of Michigan Sedation Scale (UMSS) The UMSS is a simple observational tool that assesses the level of alertness on a five-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). Score: 1- 5 |
Countries
Egypt
Outcome results
None listed