Impact of Propofol Reduction in Anesthesia Induction

NCT04194151 | Completed Phase 4 Results

• 1 other identifier: 09/17
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Determine if, by reducing the dose of propofol and increasing the time elapsed between fentanyl and propofol administration, hemodynamic response is improved. Methods: Patients were randomized into time groups (2 and 1 minute) and each subdivided into dose groups (1, 1.5 and 2 mg kg-1) obtaining six time-dose groups. After receiving 2 μg kg-1 of fentanyl, propofol was administered after the predetermined time. Time to hypnosis (BIS\<60) and hemodynamic parameters at pre-induction, pre-intubation and postintubation were registered.

Conditions

Propofol Adverse Reaction; Anesthesia

Keywords

propofol synergy; fentanyl; anesthesia induction

Outcome Measures

Primary Outcomes (3)

• Systolic Blood Pressure Variation

  Non-invasive systolic blood pressure change (%) at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

  Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

• Heart Rate Variation

  Heart rate change (%) registered at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in HR between the studied moments. Negative results mean percentage increase in HR between the studied moments.

  Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

• Systolic Blood Pressure Variation in Elderly (>55y)

  Non-invasive SBP change (%) in patients \> 55 years at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

  Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Secondary Outcomes (2)

• Time to Hypnosis

  After administration of propofol, time is measured in seconds until BIS values are less than 60

• Number of Patients Who Needed Vasoactive Drug

  1 minute after intubation

Study Arms (6)

2 minute - 2 mg/kg group

ACTIVE COMPARATOR

2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol

Drug: Propofol Injection

2 minute - 1,5 mg/kg group

ACTIVE COMPARATOR

2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol

Drug: Propofol Injection

2 minute - 1 mg/kg group

ACTIVE COMPARATOR

2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol

Drug: Propofol Injection

1 minute - 2 mg/kg group

ACTIVE COMPARATOR

2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol

Drug: Propofol Injection

1 minute - 1,5 mg/kg group

ACTIVE COMPARATOR

2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol

Drug: Propofol Injection

1 minute - 1 mg/kg group

ACTIVE COMPARATOR

2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol

Drug: Propofol Injection

Interventions

Propofol Injection DRUG

1, 1.5 or 2 mg/kg of propofol according to the subgroup

1 minute - 1 mg/kg group; 1 minute - 1,5 mg/kg group; 1 minute - 2 mg/kg group; 2 minute - 1 mg/kg group; 2 minute - 1,5 mg/kg group; 2 minute - 2 mg/kg group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who required general anesthesia
• General anesthesia with endotracheal intubation (no supraglottic devices)
• Signed informed consent
• Non-cardiac surgery
• Same anesthesiologist

You may not qualify if:

• Hemodynamic instability (systolic BP \< 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis \<0.5 ml/kg/h, central venous saturation \<60% with normal arterial saturation or lactate \>3 mmol/l)
• Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
• Suspected difficult airway
• Known allergy to anesthetic drugs

Sponsors & Collaborators

• Hospital Central de la Defensa Gómez Ulla: lead

Study Sites (1)

Hospital central de la defensa Gomez Ulla

Madrid, 28047, Spain

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Pediatric population not included. BMI not registrated. Type of surgery not registered.

Results Point of Contact

• Title: Dr. Paula Agostina VULLO
• Organization: Hospital Central de la Defensa Gomez Ulla

agosvullo@hotmail.com

+34681054151

Study Officials

• Paula A Vullo, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: aleatory assignation, time measured by nurses, drugs administrated by principal investigator
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: 2 time groups, divided into 3 dose groups

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: November 1, 2017
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)