Effect of Hypotensive Anesthesia on the Perfusion Index

Controlled Hypotension for Nasal Surgeries Clinical Trial

Official title:

Department of Anestheia and Intensive Care Unit,Cairo University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059316
• Other study ID #: N532016
• Status: Completed
• Phase: Early Phase 1
• Start date: June 10, 2016
• Est. completion date: April 21, 2017

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 21, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Controlled Hypotension for Nasal Surgeries
• Hypotension

Intervention

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

Drug:
• Nitroglycerin drug
Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins
• Labetalol
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perfusion index	perfusion index is an indication of peripheral perfusion	3hrs
Primary	serum lactate level	lactate level is an indication of central perfusion	3hrs
Secondary	surgical feild score	isan indication of adequacy of controlled hypotension	3hrs