Hypotension Drug-Induced
Conditions
Keywords
controlled hypotension, endoscopic nasal surgery, labetalol, metoprolol
Brief summary
Background: Mucosal bleeding is the most frequent complication with endoscopic nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading to increased complications, operation duration, and blood loss. There are several pharmacological techniques for the appropriate control of intraoperative bleeding. Objectives: To compare the safety and efficacy of oral labetalol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during endoscopic nasal surgeries. Patients and Methods: This is a randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for endoscopic nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group L, received oral labetalol, and group M, received oral metoprolol.
Interventions
DRUGLabetalol Hydrochloride Oral Tablet
Labetalol 200 mg
Metoprolol 100 mg
Sponsors
Damanhour Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status ≤ II * Age from 21 to 50 years * Body Mass Index (BMI) ≤ 35 kg/m2
Exclusion criteria
* ASA physical status \> II * Age \< 21 years or \> 50 years * Pregnant women * Breastfeeding * Bronchial asthma * Chronic obstructive pulmonary disease * Hypertension * Ischemic heart disease * Rheumatic heart disease * Heart failure * Heart block * Sick sinus syndrome * Sinus bradycardia * Chronic hypotension * Anemia (Hb \< 10 g/dl) * Renal or hepatic dysfunction * Central nervous system disease * Bleeding diathesis * Diabetes Mellitus * Allergic fungal sinusitis * Patients on beta-blockers, tricyclic antidepressants, alcohol or drug abuse, anticoagulation therapy, agents influencing the autonomic nervous system * Patients using pacemakers * Allergy to the study drugs * Any contraindication of oral intake
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard deviation of Blood loss (ml)(mean±SD) | 30 minutes after the end of surgery | Amount of blood loss at the end of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD) | 30 minutes after the end of surgery | Concentration of sevoflurane used during surgery |
| Mean and Standard deviation of Heart rate (beat/min.)(mean±SD) | 30 minutes after the end of surgery | Before premedication (T\_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T\_PACU) |
| Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD) | 30 minutes after the end of surgery | Before premedication (T\_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T\_PACU) |
| Number of participants and Percentage of Drug-related side effects | 30 minutes after the end of surgery | Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, Bronchospasm, and Postoperative nausea and vomiting (PONV) |
Countries
Egypt
Outcome results
None listed