Back to resultsEffect of Hypotensive Anesthesia on the Perfusion Index
Primary Purpose
Controlled Hypotension for Nasal Surgeries
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Massimo device
Nitroglycerin drug
Labetalol
Sponsored by
About this trial
This is an interventional supportive care trial for Controlled Hypotension for Nasal Surgeries focused on measuring controlled hypotension, perfusion
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
nitroglycerin group
labetalol group
Arm 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
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
Outcomes
Primary Outcome Measures
perfusion index
perfusion index is an indication of peripheral perfusion
serum lactate level
lactate level is an indication of central perfusion
Secondary Outcome Measures
surgical feild score
isan indication of adequacy of controlled hypotension
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03059316
Brief Title
Effect of Hypotensive Anesthesia on the Perfusion Index
Official Title
Department of Anestheia and Intensive Care Unit,Cairo University
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 10, 2016 (Actual)
Primary Completion Date
April 10, 2017 (Actual)
Study Completion Date
April 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Controlled Hypotension for Nasal Surgeries
Keywords
controlled hypotension, perfusion
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nitroglycerin group
Arm Type
Active Comparator
Arm 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
Arm Title
labetalol group
Arm Type
Active Comparator
Arm 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
Intervention Type
Combination Product
Intervention Name(s)
Massimo device
Intervention Description
Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin drug
Other Intervention Name(s)
tridil
Intervention Description
Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins
Intervention Type
Drug
Intervention Name(s)
Labetalol
Other Intervention Name(s)
trendate
Intervention Description
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
Primary Outcome Measure Information:
Title
perfusion index
Description
perfusion index is an indication of peripheral perfusion
Time Frame
3hrs
Title
serum lactate level
Description
lactate level is an indication of central perfusion
Time Frame
3hrs
Secondary Outcome Measure Information:
Title
surgical feild score
Description
isan indication of adequacy of controlled hypotension
Time Frame
3hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Hypotensive Anesthesia on the Perfusion Index
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