Trial Outcomes & Findings for Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia (NCT NCT00789438)

Last Updated: 2010-07-13

Results Overview

Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.

Recruitment status

COMPLETED

Target enrollment

69 participants

Primary outcome timeframe

Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay

Results posted on

2010-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	General Anesthesia Patients undergoing short-term surgery (30-90 min) under general anesthesia	Spinal Patients undergoing short-term surgery (30-90 min) under spinal anesthesia	Spinal + Sedation Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
Overall Study STARTED	21	20	28
Overall Study COMPLETED	21	20	28
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	General Anesthesia n=21 Participants Patients undergoing short-term surgery (30-90 min) under general anesthesia	Spinal n=20 Participants Patients undergoing short-term surgery (30-90 min) under spinal anesthesia	Spinal + Sedation n=28 Participants Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	52 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Age Continuous	59 years STANDARD_DEVIATION 16 • n=5 Participants	61 years STANDARD_DEVIATION 18 • n=7 Participants	62 years STANDARD_DEVIATION 17 • n=5 Participants	60 years STANDARD_DEVIATION 17 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	23 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment Germany	21 participants n=5 Participants	20 participants n=7 Participants	28 participants n=5 Participants	69 participants n=4 Participants

PRIMARY outcome

Timeframe: Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay

Outcome measures

Outcome measures
Measure	General Anesthesia n=21 Participants Patients undergoing short-term surgery (30-90 min) under general anesthesia	Spinal n=20 Participants Patients undergoing short-term surgery (30-90 min) under spinal anesthesia	Spinal + Sedation n=28 Participants Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints Median SPI at skin incision	46 SPI and delta SPI (to baseline) Standard Error 4	67 SPI and delta SPI (to baseline) Standard Error 3	40 SPI and delta SPI (to baseline) Standard Error 47

Adverse Events

General Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Spinal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Spinal + Sedation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christoph Ilies M.D.

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

Phone: +49-431-597

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place