Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension
- Conditions
- Sinus Endoscopic SurgeryDeliberate HypotensionTissue Perfusion
- Interventions
- Registration Number
- NCT03809065
- Lead Sponsor
- Cairo University
- Brief Summary
Deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery; however, hypotension might impair perfusion of vital organs. The aim of this work is to compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for induction of deliberate hypotension
- Detailed Description
Hypotensive anesthesia is associated with the risk of reduced tissue perfusion. The usual target mean arterial pressure during deliberate hypotension is 50- 65 mmHg; however, the status of peripheral perfusion under this target is not well investigated. Nitroglycerin and Labetalol are commonly used drugs to achieve deliberate hypotension. Nitroglycerin is a direct vasodilator and its main action is through venodilation, while labetalol combines a selective α1 and non selective beta-adrenergic blocking activity. Both drugs were previously compared during deliberate hypotension with regard to surgical field quality and blood loss. No study to date compared the effects of both drugs on peripheral perfusion when used for induction of deliberate hypotension. The Peripheral Perfusion Index (PPI) is the ratio between pulsatile and non-pulsatile components of peripheral circulation. Measurement of PPI is based on analysis of the pulse oximetry signal. PPI showed increasing popularity as a non invasive monitor of peripheral perfusion. Serum lactate is another frequently used marker of global tissue perfusion.The aim of this study is to compare the influence of nitroglycerin and labetalol on tissue perfusion when used for induction of deliberate hypotension during FESS operations. Tissue perfusion will be evaluated using PPI and serum lactate as markers of peripheral and global tissue perfusion respectively.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Adult male or female patients
- 18-45 years
- ASA physical status I-II
- scheduled for FESS operations
- uncontrolled hypertension
- cerebrovascular disorders
- coagulation disorders
- cardiovascular diseases
- renal impairment
- liver impairment
- history of allergic reaction to any of the study medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group N Nitroglycerin Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min . group L Labetalol Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .
- Primary Outcome Measures
Name Time Method Peripheral perfusion index 4 hours Peripheral perfusion index will be used as a marker of peripheral perfusion.
- Secondary Outcome Measures
Name Time Method Heart rate 4 hours Number of heart beats per minute
Total blood loss from beginning of surgery till the end of the procedure Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.
Mean arterial blood pressure 4 hours Target mean arterial pressure during deliberate hypotension will be 55-65mmHg
Change in serum lactate concentration Immediately before induction of anesthesia and after 60 minutes post recovery. Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.
Surgical field score (SFS) from beginning of surgery till the end of the procedure. SFS ranges from 0 to 5 as follows: 0: No bleeding, 1: Slight bleeding-no suctioning of blood required, 2: Slight bleeding-occasional suctioning required. Surgical field not threatened. 3: Slight bleeding-frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed, 4: Moderate bleeding-frequent suctioning required. Bleeding threatens surgical field directly after suction is removed, 5: Severe bleeding-constant suctioning required. Bleeding appears faster that can be removed by suction. Surgical field severely threatened and surgery not possible.
Adequate surgical field is defined as SFS \<3
Trial Locations
- Locations (1)
Kasr Al Ainy
🇪🇬Cairo, Egypt