CompletedNot Applicable

Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia

China134 participantsStarted 2020-09-01

Plain-language summary

①Effects of BIS Index (BIS) monitoring on delirium incidence in Post-anesthesia care unit (PACU) in patients undergoing general anesthesia ②Effects of BIS BIS Index (BIS) monitoring on the quality of nursing care in the Post-anesthesia care unit (PACU)

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. age ranging from 20 to 80 years
✓. estimated operation time of 2 to 3 h
✓. body mass index ≤30 kg/m2
✓. normal preoperative heart, liver, lung, and renal function.

Exclusion criteria

✕. Past cognitive impairment (dementia, cognitive impairment, mental illness or mental disorder)
✕. Complex injuries: multiple fractures, chest and abdomen, pelvic and sacral trauma, head trauma, etc
✕. Contraindications to intraspinal puncture (coagulation dysfunction, thrombocytopenia, intraspinal space occupation, puncture site infection, etc.)
✕. Have a history of acute myocardial infarction or stroke within 3 months
✕. Patients with severe liver dysfunction (Child-Pugh C) or renal failure
✕. Contraindications to ketamine, such as malignant hypertension

What they're measuring

Ricker sedation-agitation scale

Timeframe: ￭evaluate immediately after recovery and tracheal intubation removal ￭every five minutes after that ￭take the highest value until the patient leave PACU

The nursing activity score (NAS)

Timeframe: ￭at the begin of the patient enter PACU ￭end with the transfer out of the PACU ￭any nursing activitise will be scored

vital signs （Mean arterial pressure, heart rate, pulse oxygen saturation ）

Timeframe: ￭ at the beginning of surgery (T0), ￭at the time of extubation (T1), ￭10 minutes after extubation (T2), ￭at the time of leaving the PACU (T3: when patients were transferred from the PACU to the ward).

Comparison of complications during the PACU period

Timeframe: The patients were transferred to PACU after surgery, the period during the PACU

The comprehensive satisfaction score

Timeframe: The patients were followed up 24 hours after surgery

Trial details

NCT IDNCT06302517

SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-31

View on ClinicalTrials.gov More Delirium, Postoperative trials