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Comparison Between Two Drugs (Propofol and Nitroglycerin as a Hypotensive Agents During Endoscopic Sinus Surgery

NCT04220281 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-17

No results posted yet for this study

Summary

Background and Objectives: FESS is a common minimally invasive surgery that requires a clear field to be performed well. Hypotensive anesthesia is one of the most common maneuvers performed to help in keeping the field clear. An ideal drug for hypotensive anesthesia should be cheap and familial to the anesthesiologist. So being familial with propofol and by using its cardio-depressant action the idea of the research was developed and comparing it with nitroglycerin (a hypotensive agent in our protocol). Methods: The patients agreed to participate in the research were classified into two groups for comparison. Propofol group; received propofol infusion all over the procedure, and nitroglycerin group; received nitroglycerin infusion all over the procedure. Duration of surgery, visibility of surgical field and amount of blood loss were recorded. Pulse/min and MAP were recorded at baseline and every 5 min. Results: The mean duration of surgery was longer in the NTG to propofol group. There was high statistical significance in the average blood loss in the propofol group compared to NTG group. The visibility of the operative field also was significant in the propofol group as compared to NTG group. The mean heart rate in the NTG group is higher than the mean heart rate in the propofol group. The MAP in both groups is within a close range. Conclusion: Propofol and NTG can produce a safe and effective controlled hypotension during FESS. Whereas, propofol has; a better surgical field visibility, less surgical bleeding and less tachycardia during FESS.

Conditions

  • Hypotensive Anesthesia

Interventions

DRUG

Propofol

propofol infusion during surgery

DRUG

Nitroglycerin

nitroglycerin infusion during surgery

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Rasha G Abusinna, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04220281 on ClinicalTrials.gov