Anesthesia Maintenance With Target-controlled Infusion of Propofol and Remifentanil at Fixed Ratio

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorPeking University First Hospital

About this trial

The impact of anesthesia depths on early postoperative neurocognitive complications after total intravenous anesthesia (TIVA) remains controversial. In some studies investigating TIVA, anesthesiologists mainly achieve the target depth of anesthesia by adjusting the dose of propofol, whereas the doses of opioids remains comparable between different anesthetic depth groups, possibly resulting inadequate analgesia. This study is aimed to investigate the impact of different anesthesia depths maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio on the incidence of early postoperative neurocognitive complications in older patients undergoing noncardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 65 years.

Scheduled to undergo noncardiac surgery expected to last ≥ 1 hour under general anesthesia.

Require patient-controlled intravenous analgesia after surgery.

Provide written informed consent.

Disqualifiers

Inability to communicate in the preoperative period because of coma, profound dementia, language barrier, or other reasons.

Previous history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.

Traumatic brain injury or neurosurgery.

Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (eGFR <30 ml/min/1.73 m2), or critical illness (preoperative American Society of Anesthesiologists physical status classification ≥IV).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Light anesthesia

    Drug

    Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 50.

  • Deep anesthesia

    Drug

    Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 35.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Light anesthesiaExperimental treatment 1 intervention
Group B: Deep anesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of delayed neurocognitive recovery

Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better cognitove function). A decrease of 1 SD or more from baseline is defined as cognitive decline.

Time frame
On day 4 or before hospital discharge after surgery.

Secondary outcomes

1

Quality of recovery after surgery

Quality of recovery is assessed with the 15-item Quality of Recovery scale (QoR-15; scores range from 0 to 150, with higher scores indicating better quality of recovery).

Time frame
On days 1 and 3 after surgery
2

Incidence of postoperative neurocognitive disorder

Cognitive function is assessed with the telephone MoCA (T-MoCA; scores range from 0 to 20, with higher scores indicating better cognitove function). A decrease of 1 SD or more from baseline is defined as cognitive decline.

Time frame
On day 30 after surgery

Other outcomes

1

Pain intensity within 3 days after surgery

Pain intensity is assessed twice daily (8:00-10:00, 18:00-20:00) with the numeric rating scale (NRS; scores range fro 0 to 10, with 0=no pain and 10=the worst pain).

Time frame
During the first 3 days after surgery
2

Subjective sleep quality within 3 days after surgery

Subjective sleep quality is assessed once daily (8:00-10:00) with the numeric rating scale (NRS; scores range fro 0 to 10, with 0=the best sleep and 10=the worst sleep).

Time frame
During the first 3 nights after surgery
3

Percentage of ICU admission after surgery

Percentage of patients required ICU admission after surgery

Time frame
Up to 24 hours after surgery.
4

Length of hospital stay after surgery

Length of hospital stay after surgery

Time frame
Up to 30 days after surgery.

Sponsors and contacts

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