Phase 4
Completed N=63
Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery
Blood Pressure
Source: ClinicalTrials.gov NCT03850093 ↗
Enrolled (actual)
63
Serious AEs
26.7%
Results posted
Aug 2019
Primary outcomePrimary: Changes in Surgical Field Visibility — 2; 2; 4; 1 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate .
A prospective randomized double blinded controlled study. Eligible patients were randomized according to random list generated software and allocated into 3 equal and matched groups (15 patients in each group):-
* Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200 mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of anesthesia.
* Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5 mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of anesthesia.
* Group C: control group in which Patients were premedicated with oral placebo with sips of water, 2 hours before induction of anesthesia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Surgical Field Visibility |
2; 2; 4; 1; 1; 3 | — |
| PRIMARY Blood Loss |
20; 20; 80 | — |
| SECONDARY Heart Rate Change |
82.6; 73.1; 85.8; 74.9; 67.8; 85.9 | — |
| SECONDARY Mean Arterial Blood Pressure Change |
85.6; 86.4; 92.4; 74.4; 72.3; 78.2 | — |
Eligibility Criteria
Inclusion Criteria
- patients who underwent functional endoscopic sinus surgery
- ability to swallow tablets
Exclusion Criteria
- suspected difficult airway
- basal HR <60/min.
- chronic cardiovascular or cerebrovascular disease
- bronchial asthma or COPD
- DM
- bleeding disorders
- anemia (Hb level< 10 gm/dl)
- renal or hepatic insufficiency
- psychiatric disorders
- chronic treatment by BBs, gabapentin or drugs that affect coagulation
- acute nasal infection
- allergy/contraindications to any of the study's drugs.
Data sourced from ClinicalTrials.gov (NCT03850093). 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. Informational only — not medical advice.