Comparison of the quality of anesthesia and intraoperative stress responses to noxious stimulus with high opiate, low hypnotic versus low opiate high hypnotic drug administration during anesthesia using endocrinologic and immunologic markers and an off-line, post-hoc calculated surgical stress index during anesthesia with different steady-state concentrations of remifentanil and spectral entropy guided propofol administration

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003720-11-BE

Enrollment

Registered

2006-08-30

Start date

2006-09-08

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Comparing the intra-operative stress responses to noxious stimulus with high opiate, low hypnotic versus low opiate high hypnotic drug administration during anesthesia. Back surgery MedDRA version: 8.1 Level: LLT Classification code 10049130 Term: Back surgery

Interventions

Trade Name: DIPRIVAN Product Name: DIPRIVAN Product Code: 624 IS 79 F 12 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PROPOFOL CAS Number: 2078548 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • ASA I and II • male or female patients • aged 18-65 years • scheduled for surgery planned in the Operation Room schedule for more than 1 hour of duration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Weight less than 70% or more than 130% of ideal body weight • Neurological disorder • Thyroid disorder • Recent use of psycho-active medication, including alcohol. • Patients taking any medication influencing heart rate variability (such as inotropic drugs, vagolytic drugs, beta-blockers, etc…). • Patients having allergy to the study medication. • Patients with a positive pregnancy test. • Patients being included in another trial within 30 days prior to this study screening

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparing various stress markers (stress hormones, IL-6, TNF alfa levels, and telomeer lengths) with the predicted plasma concentration of opiates during two classically used regimens of anesthesia: high opiate, low hypnotic versus low opiate high hypnotic drug. Moments of high noxious stimulus (such as incision) are of special interest. ;Secondary Objective: Correlate a candidate for an on-line and real-time parameter to detect the level of surgical stress (candidate called SSI, developed by GE Healthcare Finland Oy) with the level of analgesic medication and the level of nociceptive input (e.g. during incision).;Primary end point(s): The primary efficacy measurement is to correlate the various stress markers (stress hormones, IL-6, TNF alfa levels, and telomeer lengths) with the predicted plasma concentration of opiates. In the case of remifentanil, a short acting opiate, accurate pharmacokinetic models exist to predict plasma concentrations without the need for measured concentrations. Changes in endocrinologic and immunologic markers will be analysed separately from changes in median telomere-length in lymphocytes. Comparison of the correlation will also be performed with respect to the two commonly used different anesthesia techniques employed in this study. (High opiate, low hypnotic drug versus low opiate, high hypnotic drug). Moments of high noxious stimulus (such as incision) are of special interest.	—

Measure

Time frame

Main Objective: Comparing various stress markers (stress hormones, IL-6, TNF alfa levels, and telomeer lengths) with the predicted plasma concentration of opiates during two classically used regimens of anesthesia: high opiate, low hypnotic versus low opiate high hypnotic drug. Moments of high noxious stimulus (such as incision) are of special interest. ;Secondary Objective: Correlate a candidate for an on-line and real-time parameter to detect the level of surgical stress (candidate called SSI, developed by GE Healthcare Finland Oy) with the level of analgesic medication and the level of nociceptive input (e.g. during incision).;Primary end point(s): The primary efficacy measurement is to correlate the various stress markers (stress hormones, IL-6, TNF alfa levels, and telomeer lengths) with the predicted plasma concentration of opiates. In the case of remifentanil, a short acting opiate, accurate pharmacokinetic models exist to predict plasma concentrations without the need for measured concentrations. Changes in endocrinologic and immunologic markers will be analysed separately from changes in median telomere-length in lymphocytes. Comparison of the correlation will also be performed with respect to the two commonly used different anesthesia techniques employed in this study. (High opiate, low hypnotic drug versus low opiate, high hypnotic drug). Moments of high noxious stimulus (such as incision) are of special interest.

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Countries

Belgium

Outcome results

None listed

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