Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the present study was to compare SPI guided analgesia with standard clinical practise during general anesthesia using a balanced setting of sevoflurane and sufentanil anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular stability, less use of analgetics and shorter recovery from anesthesia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SPI-guided Analgesia During FESS for Intraoperative Blood Loss

NCT03417180

Endoscopic Sinus Surgery

UNKNOWN NA

Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia

NCT00791791

Analgesia

COMPLETED NA

Desflurane and Sevoflurane on Remifentanil Requirement

NCT06123624

Spinal Diseases

NOT_YET_RECRUITING NA

Comparison of Analgesic Effect of Volatile Anesthetics

NCT02830243

Anesthesia

COMPLETED PHASE3

Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil

NCT02283866

Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

General anesthesia can be considered as a combination of hypnosis, antinociception, and immobility. The monitoring of hypnosis and immobility has been established in clinical practise, however for the evaluation of antinociception a valid monitoring is missing.

The Surgical Pleth Index (SPI; former named Surgical Stress Index-SSI) is a multivariate index derived non invasively from finger plethysmographic signal. It has been demonstrated to correlate with surgical stress intensity. In the setting of total intravenous anesthesia TIVA our group could show beneficial effects of SPI guided analgesia in terms of remifentanil consumption, hemodynamic stability and incidence of unwanted events.

Therefore, we wanted examine whether these beneficial effects of SPI guided anesthesia can be transferred to a setting of balanced anesthesia using a volatile anesthetic sevoflurane and the opioid sufentanil.

The following hypotheses have been made:

1. SPI guided analgesia will result in less sufentanil consumption
2. SPI guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia, and less opioid use in post operative period

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Balanced Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SPI guided arm

sufentanil was adjusted to SPI level

Group Type EXPERIMENTAL

administration of sufentanil

Intervention Type DRUG

10 microgram sufentanil were given when SPI above 50 for more then 20 sec

Standard practise

Sufentanil was given at standard practise

Group Type ACTIVE_COMPARATOR

sufentanil

Intervention Type DRUG

sufentanil was given at standard practise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

administration of sufentanil

10 microgram sufentanil were given when SPI above 50 for more then 20 sec

Intervention Type DRUG

sufentanil

sufentanil was given at standard practise

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age between 18 - 65 years
* ASA physical status I or II
* elective surgery under general anesthesia of 1-2 hours
* written informed consent

Exclusion Criteria

* pregnancy
* history of cardiac arrhythmia
* presence of any neuromuscular opr neurologic disease
* use of CNS active medication or alcohol/illicit drug abuse -

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No