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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L (n=30) | Active Comparator | Labetalol group |
|
| Group M (n=30) | Active Comparator | Metoprolol group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labetalol Hydrochloride Oral Tablet | Drug | Labetalol 200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean and Standard deviation of Blood loss (ml)(mean±SD) | Amount of blood loss at the end of surgery | 30 minutes after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD) | Concentration of sevoflurane used during surgery | 30 minutes after the end of surgery |
| Mean and Standard deviation of Heart rate (beat/min.)(mean±SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Shaat, MD | Damanhour Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhour Teaching Hospital | Damanhūr | El-Beheira | Egypt |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007741 | Labetalol |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Metoprolol Tartrate Oral Tablet | Drug | Metoprolol 100 mg |
|
|
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)
| 30 minutes after the end of surgery |
| Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD) | 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) | 30 minutes after the end of surgery |
| Number of participants and Percentage of Drug-related side effects | Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, Bronchospasm, and Postoperative nausea and vomiting (PONV) | 30 minutes after the end of surgery |
| D012457 |
| Salicylamides |
| D000577 | Amides |
| D000588 | Amines |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D020005 | Propanols |