Autonomic Modulation After Spinal Anesthesia With Depth of Anesthesia and Vital Signs.

NCT04275375 | Completed

• 1 other identifier: 2019-01-016CC
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anaesthesia has the advantage that produced nerve block by the injection of local anaesthetic into cerebrospinal fluid (CSF). However, the greatest challenge in spinal anaesthesia is to control the spread of local anaesthetic through the CSF to provide a block which is adequate for the proposed surgery without unnecessary extensive spread, and increased risk of complications.

Conditions

Participants Scheduled for Surgery Under Spinal Anesthesia Without Impairment of Renal, Hepatic, Cardiac or Respiratory Function

Outcome Measures

Primary Outcomes (1)

• record and compare changes in ANS function( HRV and PPGA) after spinal anesthesia in different group

  Electrocardiography and pulse photoplethysmography signals were recorded after spinal anesthesia. The spectrogram of beat-to-beat R-to-R intervals was derived by continuous wavelet transform (CWT), and the immediate power of high frequency (HFi) and low frequency (LFi) bands was extracted at 1-second intervals. The derived parameters, HF, LF, and pulse photoplethysmography amplitude, were normalized by their maximum and minimum values. Mixed-model regression and repeated-measures analysis of variance were used to explore the time-dependent effect.

  maximum for 4 hours

Study Arms (2)

hyperbaric bupivacaine

The dosage of hyperbaric bupivacaine decided by the clinical anesthesiologist. This study is an observational study.

Other: observation study about the autonomic response after spinal anesthesia

plain bupivacaine

The dosage of plain bupivacaine decided by the clinical anesthesiologist. This study is an observational study.

Other: observation study about the autonomic response after spinal anesthesia

Interventions

observation study about the autonomic response after spinal anesthesia OTHER

ECG waveforms were continuously recorded using a multichannel polygraphic system (Embla N7000, Natus, Pleasanton, CA). The data were saved at a rate of 1024 Hz directly to a memory card within the device for offline analysis of heart rate variability (HRV) and PPG. All data included in the analysis were obtained from continuous artifact-free ECG recordings for analysis of the immediate effects of spinal anesthesia.

hyperbaric bupivacaine; plain bupivacaine

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators conducted a prospective observational study on patients who were scheduled to undergo elective surgery and spinal anesthesia. The investigators excluded patients who had recently been treated with a sedative, beta-blocker, parasympatholytic, or opioid agent, patients who had undergone emergency surgery, those with hypovolemia and hypothermia, arrhythmia, diabetes, or impairment of renal, hepatic, coagulation, cardiac, or respiratory function

You may qualify if:

• \. patients scheduled for operation with spinal anesthesia

You may not qualify if:

• recently treat with a sedative, beta-blocker, parasympatholytic, or opioid agent
• emergency surgery
• hypovolemia and hypothermia, arrhythmia, diabetes, or impairment of renal, hepatic, coagulation, cardiac, or respiratory function

Sponsors & Collaborators

• National Central University: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, R.o.c, 11217, Taiwan

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 19, 2020
• Study Start: March 1, 2019
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

TW (1)