Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia.

NCT06651749 | Recruiting DMC

• 1 other identifier: FMASU MS332/2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the hemodynamic effects of a high dose versus low dose Propofol during induction of anesthesia.

Conditions

Hemodynamic Effects of Propofol

Outcome Measures

Primary Outcomes (1)

• Percentage difference of lowest mean arterial blood pressure from baseline value.

  will

  from injection till 7 minutes post-injection

Study Arms (2)

high dose propofol during induction of anesthesia.

ACTIVE COMPARATOR

this group will be given high dose propofol 2.5mg/kg during induction of anesthesia.

Drug: Propofol injection

low dose propofol during induction of anesthesia.

ACTIVE COMPARATOR

this group will be given low dose propofol 1.5mg/kg during induction of anesthesia.

Drug: Propofol injection

Interventions

Propofol injection DRUG

hemodynamic changes of a high dose versus low dose propofol during induction of anesthesia.

high dose propofol during induction of anesthesia.; low dose propofol during induction of anesthesia.

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: from 21 years old till 40 years old.
• Patients with ASA classification I and II.
• Undergoing a scheduled elective surgery.

You may not qualify if:

• Declining to give written informed consent.
• ASA classification III-V.
• Patients with class III (morbid) obesity or more (BMI \>40 Kg/m2)
• Patients with severe intraoperative hypotension requiring large volume of intravascular fluid treatment.
• Severe or uncontrolled hypertension (NIBP\> 150/100) , congestive heart failure, moderate to severe valvular heart disease , uncontrolled arrhythmia , heart rate\>100bpm .
• Significant hepatic or renal disorder.
• Patients with uncontrolled diabetes mellitus type 1 or type 2(evidenced by autonomic dysfunction or organ complications, ischemic heart disease or cerebrovascular disease).
• Patients who were pregnant (positive pregnancy test) or menstruating.
• Anemia with hemoglobin level \<9.0 g/dL
• Hypersensitivity to soybean oil, egg lecithin, or glycerol.
• Medical substance abuse.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Abbaseya, 11517, Egypt

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hadeer S Saied, M.B.B.CH

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadeer S Saied, MBBCH

CONTACT

+201021588208; hadeer.saad@med.asu.edu.eg

Hadeer S Saied, M.B.B.CH

CONTACT

+201021588208; hadeer.saad@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 22, 2024
• Study Start: November 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 31, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: before may 2025
• Access Criteria: free

Locations

EG (1)