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Observation on Administration of Propofol at Different Titration Endpoints

ConditionsAnesthesia, GeneralHemodynamics
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSanQing Jin

About this trial

Propofol has a rapid onset and short duration of action, making it widely used for induction of general anesthesia. However, its prominent drawback is circulatory depression. Our research team previously proposed an individualized dosing method for the titration of propofol. We then compared the effects of different titration rates of propofol on hemodynamics and stress during general anesthesia induction. It was found that the incidence of hypotension during the induction period was lower in the 0.5 mg/kg/min group, with lower stress levels and faster postoperative recovery. However, this group still had a 25.3% incidence of hypotension. Therefore, we plan to further study the differences in hemodynamics, depth of anesthesia, stress response, and postoperative recovery in three groups of patients induced with a constant infusion rate of propofol at 0.5 mg/kg/min titrated to an OAA/S score of 1, an OAA/S score of 2, and BIS ≤ 60, combined with remifentanil 2 μg/kg. This study aims to explore the appropriate propofol titration endpoint during general anesthesia induction to maintain stable perioperative haemodynamics and achieve rapid postoperative recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-60 years.

Elective surgery with planned endotracheal intubation under general anesthesia.

ASA classification of I or II,with heart function classified as 1 or 2.

Body Mass Index (BMI) 18-30 kg/m².

Disqualifiers

Severe cardiac, pulmonary, hepatic, or renal diseases (heart function classification greater than 3 / respiratory failure / liver failure / renal failure).

Malignant arrhythmias: atrial flutter, atrial fibrillation, atrioventricular block, frequent ventricular premature beats, multifocal ventricular premature beats, ventricular premature beats R on T, ventricular flutter, and ventricular fibrillation.

Expected difficulty with intubation, hypoalbuminemia, hypertension, or diabetes mellitus.

Patients with a high risk of aspiration due to a full stomach, gastrointestinal obstruction, or pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Titrated administration of propofol to an OAA/S score of 1 as the endpoint

    Procedure/Surgery

    Propofol is titrated at a rate of 0.5 mg/kg/min to achieve an OAA/S score of 1, followed by a maintenance dose of 2-4 mg/kg/h, concurrently with remifentanil 2 ug/kg and rocuronium 0.6 mg/kg for anesthesia induction.

  • Titrated administration of propofol to an OAA/S score of 2 as the endpoint

    Procedure/Surgery

    Propofol is titrated at a rate of 0.5 mg/kg/min to achieve an OAA/S score of 2, followed by a maintenance dose of 2-4 mg/kg/h, concurrently with remifentanil 2 ug/kg and rocuronium 0.6 mg/kg for anesthesia induction.

  • Titrated administration of propofol to a BIS value ≤ 60 as the endpoint

    Procedure/Surgery

    Propofol is titrated at a rate of 0.5 mg/kg/min to achieve a BIS value ≤ 60, followed by a maintenance dose of 2-4 mg/kg/h, concurrently with remifentanil 2 ug/kg and rocuronium 0.6 mg/kg for anesthesia induction.

Treatment groups

258 Participants
are divided into 3 treatment groups
Group A: Group OExperimental treatment 1 intervention
Group B: Group TExperimental treatment 1 intervention
Group C: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of a 30% decrease in MAP

Incidence of a 30% decrease in MAP during induction with three different titration endpoints

Time frame
During the procedure of anesthesia induction

Secondary outcomes

1

Proportion of cases with MAP < 65 mmHg

Proportion of cases with MAP \< 65 mmHg during induction in three groups

Time frame
During the procedure of anesthesia induction
2

Anesthesia depth

Anesthesia depth during induction in three groups (BIS values,pupil size and reaction to light,EEG patterns,auditory evoked potentials)

Time frame
During the procedure of anesthesia induction
3

Tracheal intubation conditions

Differences of the tracheal intubation conditions of patients among the three groups

Time frame
After finish intubation
4

Blood glucose

Blood glucose before induction,at the end of titration,and 30 seconds after endotracheal intubation in three groups

Time frame
During the procedure of anesthesia induction

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SanQing Jin

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov

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