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Effects of an EEG-based (bispectral index - BIS) induction of general anaesthesia using propofol on arterial hypotension

Effects of an EEG-based (bispectral index - BIS) induction of general anaesthesia using propofol on arterial hypotension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010544
Enrollment
240
Registered
2016-08-04
Start date
2012-02-11
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients (> 18yrs) who undergo general anesthesia for an elective procedure (ENT surgery, ophthalmic surgery and dermatologic surgery).

Interventions

Group 1: Patients who are administered propofol by weight (2mg/kg Propofol) for induction of anesthesia Group 2: Patients who were administered propofol for induction of anesthesia guided by BIS (targ

Sponsors

Uniklinikum Gießen und Marburg, Standort Marburg, Klinik für Anästhesie und Intensivtherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Eligible participants were patients aged 18 or over scheduled to undergo elective surgery (ear nose and throat (ENT) surgery, ophthalmic surgery and dermatologic surgery) under general anaesthesia.

Exclusion criteria

Exclusion criteria: Exclusion criteria were participation in another study, pregnancy and lactation, any medical condition that would require rapid sequence induction, ASA physical status > 3, any disease with a potential for compromised alertness (due to underlying disease or sedative premedication).

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the number (proportion) of patients with hypotension. Blood pressure was measured every 2 minutes during the study period (the first 12 minutes after the start of induction of anaesthesia). We defined hypotension as mean arterial pressure (MAP) < 60 mmHg in accordance with the most common definitions used to study intraoperative hypotension.

Secondary

MeasureTime frame
Secondary endpoints are: - the degree of hypotension (defined as the difference between baseline MAP and MAP at the subsequent measurements (? MAP)); - the degree of maximal hypotension (defined as the maximal difference between baseline MAP and lowest MAP (? MAP) at any of the subsequent measurments); - the ratio of hypotensive vs. normotensive MAP measurements; - the correlation between BIS-index and MAP; - the number (proportion) of patients administered vasopressors and number (proportion) of patients in whom Trendelenburg-positioning was performed at the discretion of the anaesthetist to treat a drop in blood pressure; - the number (proportion) of patients with bradycardia (heart rate 100 / min); - the number (proportion) of patients with hypertension (MAP > 140 mmHg).

Countries

Germany

Contacts

Public ContactHinnerk Wulf

Uniklinikum Gießen und Marburg, Standort Marburg, Klinik für Anästhesie und Intensivtherapie

h.wulf@med.uni-marburg.de49-6421-5862003

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026