Does Bispectral index monitoring during anesthesia provide benefit for elderly patients?

A prospective, randomized evaluation of utility of Bispectral index monitoring in elderly surgical patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42029636

Enrollment

125

Registered

2015-03-17

Start date

2006-04-01

Completion date

Unknown

Last updated

2015-07-06

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

Conditions

Improved outcome after anesthesia by more precise administration of anesthetics in relation to individual need as assessed by bispectral index monitoring. Surgery Anesthesia

Interventions

In study groups Bispectral index is recorded in all subjects but only available for guiding administration of anesthetics in the "open" group as opposed to the "concealed" group in which data is recor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 70, both gender 2. Anticipated duration of surgery over 90 minutes 3. Being able to communicate in Swedish 4. No overt hearing or reading difficulties

Exclusion criteria

Exclusion criteria: 1. Unstable medical condition starting after inclusion but prior to surgery 2. Psychiatric disease 3. Reoperation 4. Lost to follow-up 5. Result from mini mental state examination <23

Design outcomes

Primary

Measure	Time frame
Postoperative cognitive dysfunction day 7 after surgery, global cardio-vascular outcome score (based on 10 subparameters), and global socio-economic outcome score ( based on 8 subparameters)	—

Secondary

Measure	Time frame
Intraoperative blood loss, net fluid and blood balance, urine production first 6 h postoperatively, postoperative hypoxemia (defined as SpO2 below 90%), increase in C-reactive protein postoperative day 3, weight gain postoperative day 3, awareness, 7 subparameters reflecting postoperative cognitive decline as described by Moller et al. (Lancet 1998; 351: 857-61), increase in Troponin-I 12-24 h after surgery, increase in Troponin-I 72 h after surgery, average intraoperative mean arterial blood pressure, duration of heart rate deviating >20% from baseline intraoperatively, duration of heart rate deviating >20% from baseline postoperatively, duration of systolic arterial blood pressure deviating >20% from baseline intraoperatively, duration of systolic arterial blood pressure deviating >20% from baseline postoperatively, duration of intraoperative inotropic support, number of patients given inotropic support postoperatively, duration of inotropic support postoperatively, age corrected average MAC-fraction of sevoflurane administered during anesthesia, duration of stay at the postoperative care unit, number of påatioents admitted to the ICU postoperatively, duration of sotal stay at the postoperative care unit and intensive care unit, length of hospital stay, number of patients being discharged to home, 30-day survival, 1-year survival.	—

Measure

Time frame

Intraoperative blood loss, net fluid and blood balance, urine production first 6 h postoperatively, postoperative hypoxemia (defined as SpO2 below 90%), increase in C-reactive protein postoperative day 3, weight gain postoperative day 3, awareness, 7 subparameters reflecting postoperative cognitive decline as described by Moller et al. (Lancet 1998; 351: 857-61), increase in Troponin-I 12-24 h after surgery, increase in Troponin-I 72 h after surgery, average intraoperative mean arterial blood pressure, duration of heart rate deviating >20% from baseline intraoperatively, duration of heart rate deviating >20% from baseline postoperatively, duration of systolic arterial blood pressure deviating >20% from baseline intraoperatively, duration of systolic arterial blood pressure deviating >20% from baseline postoperatively, duration of intraoperative inotropic support, number of patients given inotropic support postoperatively, duration of inotropic support postoperatively, age corrected average MAC-fraction of sevoflurane administered during anesthesia, duration of stay at the postoperative care unit, number of påatioents admitted to the ICU postoperatively, duration of sotal stay at the postoperative care unit and intensive care unit, length of hospital stay, number of patients being discharged to home, 30-day survival, 1-year survival.

—

Countries

Sweden

Outcome results

None listed

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