Impact of Propofol Reduction in Anesthesia Induction

NCT ID: NCT04194151

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-10-26

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.

Detailed Description

A minimum of 162 patients were required, considering an expected Mean Difference of 5 with expected Standard Deviation of 22, confidence level of 95% and power of 80%. Estimating a possible loss of 15%, it was raised to 192. Consecutive identification numbers were assigned and the sample was randomized in six groups of 32 patients according to time and dose of propofol.

Pre-oxygenation was performed until the expired oxygen fraction exceeded 80% and 2 µg/kg of intravenous fentanyl were administered. Depending on the study group, 1 or 2 minutes were allowed to pass and 1, 1.5 or 2 mg/kg of propofol were supplied (prior administration of intravenous lidocaine 0.5 mg/kg). The time in which the BIS dropped below 60 was recorded. If it did not reach that level after two minutes or when it exceeded it but then rose above 60 again, an extra dose of propofol of 0.5 mg/kg was administered. Muscle relaxation was performed with rocuronium 0.6 mg/kg. The patient was manually ventilated until endotracheal intubation was performed by the same experienced anaesthesiologist and connected to mechanical ventilation.

Data were collected manually. Statistical analysis was performed using SPSS ver. 22. Inferential statistics were performed using t-test for quantitative variables, chi-square for qualitative and ANOVA for qualitative and quantitative comparisons. Non-parametric statistical tests were used when necessary. Confidence intervals were estimated at a level of 95% and a P value of <.05 was considered statistically significant.

Conditions

Propofol Adverse Reaction; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

2 minute - 2 mg/kg group

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

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

2 minute - 1,5 mg/kg group

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

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

2 minute - 1 mg/kg group

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

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

1 minute - 2 mg/kg group

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

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

1 minute - 1,5 mg/kg group

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

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

1 minute - 1 mg/kg group

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

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

Interventions

Propofol Injection

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Central de la Defensa Gómez Ulla

OTHER

Sponsor Role: lead

Responsible Party

paula agostina vullo

Sponsor-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula A Vullo, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital central de la defensa Gomez Ulla

Madrid, , Spain

Countries

Spain

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

09/17

Identifier Type: -

Identifier Source: org_study_id