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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000487617
• Date of registration: 09/05/2014
• Prospective Registration: Yes
• Primary sponsor: Hopital Militaire Principal d'Instruction de Tunis
• Public title: Is bispectral index monitoring useful to assess the quality of analgesia in patients under general anesthesia?
• Scientific title: Induction of general anesthesia and laryngoscopy with and without remifentanil: can bispectral index predict and/or detect the lack of analgesia?
• Date of first enrolment: 12/05/2014
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614000487617.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Tunisia

Contacts

• Name: Dr Abderrahmen Bargaoui

• Name: Mr Abderrahmen Bargaoui

Key inclusion & exclusion criteria

Inclusion criteria: - ASA class 1 or 2.
- Proposed for elective surgery.
Exclusion criteria: - Predicted difficult intubation.
- Hard-to-control hypertension.
- Coronaropathy.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Other anaesthesiology

General anesthesia;Analgesia;measuring depth of anesthesia;
General anesthesia
Analgesia
measuring depth of anesthesia

Intervention(s)

- 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.

Primary Outcome(s)

Difference in DeltaBIS (maximum of BIS after laryngoscopy - BIS before laryngoscopy) between the P and the PR group.[2 minutes after laryngoscopy]

Secondary Outcome(s)

Correlation between DeltaBIS and DeltaArterialPressure. Arterial pressure is assessed by automated pneumatic cuff.[2 minutes after laryngoscopy]

Correlation between DeltaBIS and DeltaHeartRate. Heart rate is assessed by continuous electrocardiogram.[2 minutes after laryngoscopy]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Hopital Militaire Principal d'Instruction de Tunis

Ethics review

Status: Not approved
Approval date:
Contact:

Comité d'ethique local de l'Hopital Militaire de Tunis