Effect of Hypotensive Anesthesia on the Perfusion Index

Cairo University (CU)

Status and phase: Completed; Early Phase 1

Conditions: Controlled Hypotension for Nasal Surgeries

Treatments: Drug: Nitroglycerin drug; Drug: Labetalol; Combination Product: Massimo device

Study type: Interventional

Funder types: Other

Identifiers

NCT03059316

N532016

Details and patient eligibility

About

Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Many medications were used to induce hypotension. In this study we will compare the effects of tridil and labetalol on the perfusion.

Full description

The purpose of this study to detect the degree of hypotension that helps the surgeon and dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and labetalol infusions on the perfusion.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I-II males and females aged 18-45 years who were scheduled for Functional Endoscopic sinus surgery (FESS)

Exclusion criteria

• uncontrolled hypertension, cerebrovascular disorders, bleeding and coagulation disorders, coronary artery diseases, renal or hepatic diseases or known hypersensitivity to the drugs used and pregnant.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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40 participants in 2 patient groups

nitroglycerin group

Active Comparator group

Description:

this group will receive nitroglycerin infusion for controlled hypotension.0.5-5ug/kg/min to keep MAP 55-65mmhg then Massimo device will be attached to the patients when MAP reached the desired level

Treatment:

Combination Product: Massimo device

Drug: Nitroglycerin drug

labetalol group

Active Comparator group

Description:

this group will receive labetalol infusion fo controlled hypotension 0.4-3mg/kg/hr to keep MAP 55-65mmhg.then Massimo device will be attached to the patients when MAP reached the desired level

Treatment:

Drug: Labetalol

Combination Product: Massimo device