Hemodynamic Instability Clinical Trial
Official title:
Efficacy of Dexmedetomidine Infusion Without Loading Dose on Hemodynamic Variables and Recovery Time During Craniotomy: A Randomized Double Blinded Controlled Study
Verified date | February 2021 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | January 26, 2021 |
Est. primary completion date | January 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean areterial blood pressure | incidence of intraoperative hemodynamic stability | 4 to 8 hours | |
Primary | Heart rate | incidence of intraoperative hemodynamic stability | 4 to 8 hours | |
Primary | Number of Participants needed rescue agents | 4 to 8 hours | ||
Secondary | Recovery time in minutes | Recovery time in minutes (time interval between discontinuation of isoflurane and extubation). | At the end of operation | |
Secondary | Postoperative sedation level | 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 | 1st 2 hours postoperatively |
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