NCT01525537

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

January 26, 2012

Last Update Submit

June 14, 2012

Conditions

Balanced Anesthesia

Keywords

Anesthesia GeneralAnesthetics InhalationDiagnostic techniques and procedures

Outcome Measures

Primary Outcomes (1)

  • Sufentanil consumption

    We will measure the sufentanil consumption during beginning of anesthesia and extubation in microgram per hour.

    during induction and end of anesthesia (1-3 hours)

Secondary Outcomes (1)

  • hemodynamic stability

    from beginning of anesthesia until discharge to ward (1day)

Study Arms (2)

SPI guided arm

EXPERIMENTAL

sufentanil was adjusted to SPI level

Drug: administration of sufentanil

Standard practise

ACTIVE COMPARATOR

Sufentanil was given at standard practise

Drug: sufentanil

Interventions

administration of sufentanilDRUG

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

SPI guided arm
sufentanilDRUG

sufentanil was given at standard practise

Standard practise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.

Kiel, 24105, Germany

Location

Related Publications (3)

  • Chen X, Thee C, Gruenewald M, Wnent J, Illies C, Hoecker J, Hanss R, Steinfath M, Bein B. Comparison of surgical stress index-guided analgesia with standard clinical practice during routine general anesthesia: a pilot study. Anesthesiology. 2010 May;112(5):1175-83. doi: 10.1097/ALN.0b013e3181d3d641.

    PMID: 20418698BACKGROUND

  • Gruenewald M, Meybohm P, Ilies C, Hocker J, Hanss R, Scholz J, Bein B. Influence of different remifentanil concentrations on the performance of the surgical stress index to detect a standardized painful stimulus during sevoflurane anaesthesia. Br J Anaesth. 2009 Oct;103(4):586-93. doi: 10.1093/bja/aep206. Epub 2009 Jul 31.

    PMID: 19648155BACKGROUND

  • Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.

    PMID: 24535604DERIVED

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Berthold Bein, MD, PhD

    University Hospital Schleswig-Holstein

    STUDY CHAIR

  • Matthias Gruenewald, MD

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 26, 2012

First Posted

February 3, 2012

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

October 1, 2011

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

DE(1)