Hemodynamics During Induction of General Anesthesia With Medium or Low Remifentanil Doses.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2022-02-02

Brief Summary

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In this trial the investigators want to examine if there is any difference in hemodynamic stability during induction when comparing two low and a medium remifentanil dose and keeping propofol induction dose at about 2.0 mg/kg.

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Detailed Description

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Typically, one or more adjuvant medications is administered during induction of general anesthesia. When anesthetic drugs are combined, the hypnotic effects are often synergistic. Propofol is associated with hypotension and bradycardia and used together with remifentanil or sedative agents it may give synergistic or additive sedative and hemodynamic effects.

Remifentanil is infused at 0.05-0.3 microg/kg/min during induction of anesthesia. Some use a loading dose of 0.5-1.0 microg/kg before starting the continuous infusion. The onset of action of remifentanil is within one to two minutes and it reaches rapidly a steady state effect site concentration after a bolus dose.

Kazmaier (2000) showed that a high-dose remifentanil anesthesia (2 microg/kg/min) reduced cardiac index (-25%), stroke volume (-14%) and mean arterial blood pressure (-39%) in a similar manner as propofol/remifentanil (propofol target 2 microg/ml and remifentanil 0.5 microg/kg/min), but systemic vascular resistance index decreased (-14%) in propofol/remifentanil combination. Fairfield et al have earlier (1991) showed that propofol 2.5 mg/kg induction without opioid reduces cardiac output (-15%) stroke volume (-5 %), mean arterial pressure (-33%) and systemic vascular resistance (-11%) and a slight reduction i heart rate. Guarracino (2003) suggests the reduction in cardiac index during induction with propofol/remifentanil with a low propofol target (1.2 microg/ml) may be due to decreased heart rate. Zaballos (2009) have shown that remifentanil depresses sinus node and atrioventricular (AV) -nodal function in comparison with propofol alone in a closed chest porcine model. Hayashi (2016) states that even in a low remifentanil effect site concentration (3.5 nanog/ml) it may reduce heart rate significantly when combined with propofol bolus 30-50 mg.

Conditions

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Hemodynamic Instability Anesthesia, General Anesthesia, Intravenous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, double blind.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomization made by a person not involved in trial in other ways. Allocation masked in sealed envelopes, stored in a locked cash box only opened by two drug preparing nurses not involved in patient care. Syringe labelled with patient identification (ID) (eg 03Remi). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.

Study Groups

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Remifentanil R2

Low dose Remifentanil induction dose (R2)

Group Type ACTIVE_COMPARATOR

Remifentanil R2

Intervention Type DRUG

0,7 microg/kg

Remifentanil R4

Medium dose Remifentanil induction dose (R4)

Group Type ACTIVE_COMPARATOR

Remifentanil R4

Intervention Type DRUG

1,1 microg/kg

Remifentanil R8

Medium dose Remifentanil induction dose (R8)

Group Type ACTIVE_COMPARATOR

Remifentanil R8

Intervention Type DRUG

1,7 microg/kg

Interventions

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Remifentanil R2

0,7 microg/kg

Intervention Type DRUG

Remifentanil R4

1,1 microg/kg

Intervention Type DRUG

Remifentanil R8

1,7 microg/kg

Intervention Type DRUG

Other Intervention Names

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Ultiva Ultiva Ultiva

Eligibility Criteria

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Inclusion Criteria

* Gynecological procedure
* Age 18-50 years
* General anesthesia planned
* Systolic blood pressure \< 150 mmHg, HR \< 100 beats/min

Exclusion Criteria

* Pre-existing hypertension
* Diabetes
* Ischemic heart disease or cerebrovascular disease
* Heart valve disease
* Verified cardiac arrhythmia other than extrasystoles
* Verified anaemia with hemoglobin level below 9.0 gr/dl.
* Kidney or hepatic disease
* Hypersensitivity for propofol, soya, eggs or peanuts
* Pregnancy
* Poor health state
* Illicit substance use
* BMI \<20 or \>35 kg/m2

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No