Effect of Hypotensive Anesthesia on the Perfusion Index

NCT03059316 | Completed Early Phase 1 DMC

• 1 other identifier: N532016
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Controlled Hypotension for Nasal Surgeries

Keywords

controlled hypotension, perfusion

Outcome Measures

Primary Outcomes (2)

• perfusion index

  perfusion index is an indication of peripheral perfusion

  3hrs

• serum lactate level

  lactate level is an indication of central perfusion

  3hrs

Secondary Outcomes (1)

• surgical feild score

  3hrs

Study Arms (2)

nitroglycerin group

ACTIVE COMPARATOR

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

Combination Product: Massimo device; Drug: Nitroglycerin drug

labetalol group

ACTIVE COMPARATOR

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

Combination Product: Massimo device; Drug: Labetalol

Interventions

Massimo device COMBINATION_PRODUCT

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

labetalol group; nitroglycerin group

Nitroglycerin drug DRUG

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

Also known as: tridil

nitroglycerin group

Labetalol DRUG

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

Also known as: trendate

labetalol group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Nitroglycerin; Labetalol

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Salicylamides; Amides; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of anesthesia and intensive care unit,Cairo university

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 23, 2017
• Study Start: June 10, 2016
• Primary Completion: April 10, 2017
• Study Completion: April 21, 2017
• Last Updated: March 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share