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Is bispectral index monitoring useful to assess the quality of analgesia in patients under general anesthesia?

Induction of general anesthesia and laryngoscopy with and without remifentanil: can bispectral index predict and/or detect the lack of analgesia?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000487617
Enrollment
60
Registered
2014-05-09
Start date
2014-05-12
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Bispectral index is a device used to monitor depth of anesthesia. Studies showed that it was well correlated with hypnotics, especially when used alone. Some data suggest that it can detect lack of analgesia. Our primary purpose was to test the ability of bispectral index to detect and/or predict the quality of analgesia.

Interventions

- Patients were randomized in 2 groups. - Group P: induction of anesthesia performed by propofol alone. - Group PR: induction of anesthesia performed by propofol and remifentanil. - Propofol administration was performed in the 2 groups by target-controlled infusion (TCI) using Schnider model. We targeted a plasmatic concentration of 6ug/ml obtained over 2 minutes. - Remifentanil administration was performed in the PR group by TCI using Minto model. We targeted a cerebral concentration of 4ng/ml

- Patients were randomized in 2 groups. - Group P: induction of anesthesia performed by propofol alone. - Group PR: induction of anesthesia performed by propofol and remifentanil. - Propofol administration was performed in the 2 groups by target-controlled infusion (TCI) using Schnider model. We targeted a plasmatic concentration of 6ug/ml obtained over 2 minutes. - Remifentanil administration was performed in the PR group by TCI using Minto model. We targeted a cerebral concentration of 4ng/ml. - We noted the arterial pressure, heart rate and bispectral index (BIS) each minute. - As BIS reached 60, consumption and cerebral concentration of propofol and time elapsed since the initiation of the induction were noted. Then, we fixed the plasmatic concentration of propofol to the cerebral concentration noted. - A muscle relaxing agent was administered and a laryngoscopy with endotracheal intubation was performed. - BIS, heart rate and arterial pressure were noted before and in the 2 minutes following laryngoscopy.

Sponsors

Hopital Militaire Principal d'Instruction de Tunis
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

- ASA class 1 or 2. - Proposed for elective surgery.

Exclusion criteria

- Predicted difficult intubation. - Hard-to-control hypertension. - Coronaropathy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026