Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia

NCT ID: NCT00789438

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-05-31

Brief Summary

The Surgical Pleth index (SPI) has been introduced as a non invasive tool to "measure" stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with propofol and remifentanil. These trials showed a good correlation between SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure 'pain' during surgery. So far, no study investigated SPI during regional anaesthesia.

Detailed Description

1. Spinal anaesthesia secures full pain relieve and muscle relaxation usually in the lower part of the body. Thus, SPI - a measure that reflects pain during surgery - may not exceed significantly compared to baseline. It may slightly increase only during administration of the block.

2. Increasing SPI values due to surgery under subarachnoid block may reflect intraoperative patient's stress mediated by activation of the autonomic nervous system, specifically sympathetic activation.

3. In consistence with previously published data no changes of SPI should occur due to standardized sedation with propofol.

Conditions

Stress; Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

General Anesthesia

Patients undergoing short-term surgery (30-90 min) under general anesthesia

No interventions assigned to this group

Spinal

Patients undergoing short-term surgery (30-90 min) under spinal anesthesia

No interventions assigned to this group

Spinal + Sedation

Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• surgical procedures feasible under general or spinal anesthesia
• duration between 30 and 90 min
• ASA status I,II or III

Exclusion Criteria

• contraindications against one of the anesthesia methods
• age under 18
• emergencies
• chronical pain history
• lack of sinus rhythm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Institut für Anästhesiologie und Operative Intensivmedizin, Campus Kiel

Principal Investigators

Berthold Bein, PD Dr med

Role: STUDY_DIRECTOR

Institut für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel

Locations

Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Countries

Germany

Other Identifiers

SSI-154-02

Identifier Type: -

Identifier Source: org_study_id