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

NCT04220281 | Terminated Phase 1

• 1 other identifier: RGAbusinna
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

propofol; nitroglycerin

Outcome Measures

Primary Outcomes (1)

• efficacy of propofol infusion as a hypotensive agent in comparison with nitroglycerin infusion in FESS surgeries under general anesthesia

  measuring MAP every 5 min all over the time of surgery comparing the two study groups (propofol infusion versus nitroglycerin infusion)

  the study data collected during the time of surgery ranging from 1-2 hours

Secondary Outcomes (3)

• measuring the pulse rate

  the study data collected during the time of surgery ranging from 1-2 hours

• visibility of the surgical field by using the Average Category Scale

  done by the surgeon immediately after the surgery

• amount of blood loss

  done by the anesthetist every 1 hour during the surgery

Study Arms (2)

propofol group

ACTIVE COMPARATOR

propofol group will receive propofol infusion

Drug: Propofol

nitroglycerin group

ACTIVE COMPARATOR

will receive nitroglycerin infusion

Drug: Nitroglycerin

Interventions

Propofol DRUG

propofol infusion during surgery

Also known as: prop

propofol group

Nitroglycerin DRUG

nitroglycerin infusion during surgery

Also known as: NTG

nitroglycerin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients ASA I and II diagnosed for chronic sinusitis
• Age range between 18-60 years, undergoing elective FESS without septoplasty under general anesthesia.

You may not qualify if:

• included any patient with bleeding disorder, on anticoagulant therapy
• renal, hepatic or cardiac dysfunction
• history of cerebrovascular stroke
• peripheral vascular diseases
• allergic to any of the study drugs
• hypertension
• morbid obesity and
• recurrent endoscopic sinus surgeries

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, EL Abassia, 11591, Egypt

Location

MeSH Terms

Interventions

Propofol; Nitroglycerin

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitro Compounds

Study Officials

• Rasha G Abusinna, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care, Principal Investigator

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 7, 2020
• Study Start: December 1, 2019
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

EG (1)