Effect of Hypotensive Anesthesia on the Perfusion Index

Department of Anestheia and Intensive Care Unit,Cairo University

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03059316

Enrollment

Registered

2017-02-23

Start date

2016-06-10

Completion date

2017-04-21

Last updated

2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Controlled Hypotension for Nasal Surgeries

Keywords

controlled hypotension, perfusion

Brief summary

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.

Detailed 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.

Interventions

COMBINATION_PRODUCTMassimo device

Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).

DRUGNitroglycerin drug

Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins

DRUGLabetalol

Labetalol is an antagonist of adrenergic receptors (a1, b1, b2) which is used as an hypotensive inducer. This drug targets the beta receptors 5 to 10 times more specific than alpha receptors so that minor tachycardia happens

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
perfusion index	3hrs	perfusion index is an indication of peripheral perfusion
serum lactate level	3hrs	lactate level is an indication of central perfusion

Secondary

Measure	Time frame	Description
surgical feild score	3hrs	isan indication of adequacy of controlled hypotension

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026