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CVI BIS study.

Measurement of nociception and prediction of movement during combined general epidural anesthesia in ASA I-III patients undergoing major abdominal surgery using bilateral frontal EEG measurements and hemodynamic parameters .

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24098
Enrollment
60
Registered
2010-01-27
Start date
2009-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

In the current study we will measure CVI as a measure of adequate analgesia in ASA 1-3 patients during elective abdominal surgery under fentanyl/sevoflurane/epidural anesthesia. We will monitor patient movement as primary correlate to CVI and cardiovascular parameters as secondary correlates (eg, cardiac output, pulse transit time, blood pressure and heart rate).

Interventions

Sixty ASA I-III patients for elective abdominal surgery will be given an epidural catheter prior to induction. After placement of the catheter, anesthesia will be started either with the epidural anes

Sponsors

Leiden University Medical Center, dept of Anesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18-80 years; 2. Sex: Male or female; 3. Surgery: Elective abdominal surgery lasting at least 2 hours. This includes gynecological procedures (eg., abdominal hysterectomies), urological procedures (eg., radical prostatectomies), GI-surgery (eg., colon surgery); 4. ASA status: 1, 2 or 3.

Exclusion criteria

Exclusion criteria: 1. Age: 80 years; 2. Unable to give written informed consent; 3. Pregnancy/lactation; 4. Extreme obesity: BMI > 35; 5. Perceived difficult intubation requiring muscle relaxation.

Design outcomes

Primary

MeasureTime frame
We will monitor patient movement and corresponding CVI & BIS values as a measure of adequate pain relief during surgery.

Secondary

MeasureTime frame
Any change in cardiovascular variables. Cardiovascular monitoring will include: Pulse transit time (PTT), heart-rate, blood pressure and cardiac output as calculated from the arterial pressure pulse wave.

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)