ANI and SPI Guided Intraoperative Analgesia

NCT02490540 | Completed

• 1 other identifier: 201506S 38P
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

There is accumulating evidence that inappropriate analgesia is asssociated with increasing risk of perioperative complications. The aim of the study is to compare intraoperative analgesia guided according to different methods of intraoperative analgesia monitoring, ANI and SPI respectively.

Conditions

Anesthesia

Keywords

opioids; analgesia; pain; anesthesia

Outcome Measures

Primary Outcomes (1)

• Cortisol serum level

  nmol/l

  End of surgery

Secondary Outcomes (14)

• Time to spontaneous ventilation

  From the end of anesthesia up to two hours

• Time to extubation

  From the end of anesthesia up to two hours

• Pain intensity at the time of departure from the operating theater

  At the time of departure from the operating room, up to 30 min from the end of anesthesia

• Pain intensity at recovery room admission

  At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission

• Mean pain intensity at the ICU/recovery room

  From the admission to the ICU or recovery room up to 2 hours postoperatively

Study Arms (3)

Anesthesiologist quided analgesia

EXPERIMENTAL

Sufentanil anesthesiologist analgesia is based on anesthesiologist decision.

Drug: Sufentanil anesthesiologist analgesia

ANI guided analgesia

EXPERIMENTAL

Sufentanil ANI analgesia based on ANI analgesia monitor figures.

Drug: Sufentanil ANI analgesia

SPI guided analgesia

EXPERIMENTAL

Sufentanil SPI analgesia is based on the SPI analgesia monitor figures.

Drug: Sufentanil SPI analgesia

Interventions

Sufentanil SPI analgesia DRUG

Sufentanil is given based on SPI value in the SPI guided analgesia group. The targer SPI range is set indiviudally based on the initial value of SPI recorded 5 minutes after the induction of anesthesia plus 10 points. In the ANI group, Sufentanil is given based on the ANI value, the target ANI range is 50 - 70. Values lower than 49 for 1 minute indicate the need of administering further dose of opioid, sufentanil is given in the same dose as initially. In the anesthesiologist guided analgesia group, Sufentanil is administered in a standardized manner.

Also known as: Sufentanil, SPI

SPI guided analgesia

Sufentanil ANI analgesia DRUG

Sufentanil is given based on ANI analgesia monitor figures in the sufentanil ANI analgesia group. Targeted ANI range is 50 - 70. Figures lower than 49 for 1 minute indicate the need of administering further dose of opioid, sufentanil is given in the same dose as initially and flushed with 20 ml of saline. The next dose of opioid can be given in the earliest after 3 minutes interval, if indicated according to ANI monitoring. The doses are repeated up to achievement of the targeted range of analgesia (ANI). The last dose of opioid can be given no later than 15 minutes before the end of surgery.

Also known as: Sufentanil, ANI

ANI guided analgesia

Sufentanil anesthesiologist analgesia DRUG

Sufentanil is given based on the anesthesiologist decision in the sufentanil anesthesiologist analgesia group. Sufentanil is administered in 20 minute intervals in a standardized manner, the same dose as initially is given and flushed with 20 ml of saline. Indication for additional administration of opioid beyond this interval is 25 % increase of systemic arterial pressure over the baseline and/or 35% increase of heart rate over the baseline. The next dose of opioid can be given in the earliest after 3 minutes interval. The doses are repeated up to achievement of the haemodynamic stability. The last dose of opioid can be given no later than 15 minutes before the end of surgery.

Also known as: Sufentanil, anesthesiologist

Anesthesiologist quided analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing scheduled neurosurgical procedures under general anesthesia
• GCS 15
• ASA physical status I - III
• elective procedures with estimated duration 1 - 3 hours

You may not qualify if:

• Presence of non-sinus rhythm
• pacemaker
• planned postoperative ventilation
• procedures with planned awake intervals
• chronic pain with opioid medication
• opioid addiction
• epidural administration of local anaesthetic in combination with opioid
• corticosteroid use
• hormonal contraception
• chronic respiratory disease with known respiratory failure

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Sufentanil; Anesthesiologists

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthetists; Health Personnel; Health Care Facilities Workforce and Services; Physicians

Study Officials

• Vlasta Dostalova, MD, PhD

  University Hospital Hradec Kralove

  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: Dr.

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 7, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CZ (1)