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Postoperative time of extubation and incidence of postoperative nausea and vomiting due to intraoperative pupillometry-controlled analgesia

Postoperative time of extubation and incidence of postoperative nausea and vomiting due to intraoperative pupillometry-controlled analgesia - P_AL_EX

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012329
Enrollment
200
Registered
2017-05-24
Start date
2018-05-24
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

postoperative nausea and vomiting analgesia

Interventions

Group 1: Control group: allocation due to randomisation, Intraoperative opioid administraion (sufentanil) control by clinical parameters (eg heart rate, blood pressure, BIS (bispectraler Index), sweat

Sponsors

Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: voluntariness; preoperative written confirmed consent, elective surgery with use of heart-lung machine or implantation of transapical aortic valve (TAVI), adequate knowledge of the German language, 18 years of age

Exclusion criteria

Exclusion criteria: 8.5%, concomitant treatment with opioids or antidepressants, eye drugs for topical application, psychiatric disorder. Secondary: BDI > 20 points, early postoperative complications, intraopertive injection of atropine, MCP/ DHB, intraopertive hypothermia <32°C.

Design outcomes

Primary

MeasureTime frame
• Patients who undergo elective cardiac surgery and receive intraoperative opioids due to pupillometry will be extubated earlier than patients who receive opioids due to clinical parameters (without pupillometry) • Patients with cardiac surgery and intraoperative analgesia due to pupillometry will suffer less postoperative nausea and vomiting than patients who receive opioids due to clinical parameters (without pupillometry)

Secondary

MeasureTime frame
• Postoperative pain (NRS, numerical rating scale, 0-10) on day one and day two after surgery • Incidence of re-Intubation with early respiratory insuffiency (< 24h after extubation). • Intraoperative consumption of analgesics • Postoperative consumption of analgesics on day one and day two after surgery. • Incidence of postoperative delirium on day one and two after surgery. • Intraoperative correlation between pupillometry and BIS. • gender difference for all diagnosed parameter (z.B. PONV, NRS pupil diameter). • Incidence rate on further postoperative complications on day one and two after surgery.

Countries

Germany

Contacts

Public ContactChristine Meyer-Frießem

Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum

meyer-friessem@ains-bergmannshei.de0049234-3020

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026