Skip to content

Effect of perioperative ketamine on postoperative cognition – a randomized placebo-controlled trial

Effect of perioperative ketamine on postoperative cognition – a randomized placebo-controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20273
Enrollment
50
Registered
2014-10-20
Start date
2014-09-17
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

postoperative cognitive decline

Interventions

The pharmacy will randomize patients to receive placebo (normal saline
placebo group) or ketanest (S(+)-ketamine
Eurocept BV, Ankeveen, NL) according to the LUMC protocol. This protocol states: 1. Initiate administration prior to surgical incision 2. Start with an intravenous bolus administration of 0.35 mg/kg

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients planned for elective surgery lasting > 2 1 h that require postoperative pain relief will be enrolled in the study after written informed consent is obtained.

Exclusion criteria

Exclusion criteria: Exclusion criteria: • age 35 kg/m2, • history or present psychiatric disease, • untreated/uncontrolled hypertension (with a diastolic blood pressure > 100 mmHg) • epilepsy, • increased intracranial pressure, • untreated hypertension, • untreated ischemic cardiac disease, • inability to communicate in the Dutch language, • inability to give informed consent.

Design outcomes

Primary

MeasureTime frame
• To assess the effect of perioperative ketamine on postoperative cognitive function on day 1 and 30 following surgery.

Secondary

MeasureTime frame
• To assess the effect of perioperative ketamine on postoperative pain and perioperative analgesics consumption on days 1 and 2 following surgery and persistent pain as measured on day 30 following surgery. • To assess the effect of perioperative ketamine on depth of anesthesia and sedation (postoperatively) and nociceptive level during anesthesia. • To assess side effects during ketamine administration: hypertension, tachycardia, nausea/vomiting, psychomimetic side effects, lightheadedness/dizziness, drug high and elevated liver enzymes. • The assess the effect of ketamine on inflammatory marker C-reactive protein on day 1 after surgery.

Contacts

Public ContactM. Velzen, van

LUMC, Anesthesiology, P5 Albinusdreef 2

m.van_velzen@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)