ANI and SPI Guided Intraoperative Analgesia

NCT ID: NCT02490540

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-11-30

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.

Detailed Description

The Surgical Pleth Index (SPI) and ANI (Analgesia Nociception Index) has been developed for monitoring of adequacy of analgesia during surgery.

The investigators want to compare anesthesiologist guided intraoperative analgesia with intraoperative analgesia guieded by ANI or SPI.

The following hypotheses have been made:

1. Anesthesiologist guided analgesia will result in lower surgical stress

2. Anesthesiologist guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Anesthesiologist quided analgesia

Sufentanil anesthesiologist analgesia is based on anesthesiologist decision.

Group Type: EXPERIMENTAL

Sufentanil anesthesiologist analgesia

Intervention Type: 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.

ANI guided analgesia

Sufentanil ANI analgesia based on ANI analgesia monitor figures.

Group Type: EXPERIMENTAL

Sufentanil ANI analgesia

Intervention Type: 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.

SPI guided analgesia

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

Group Type: EXPERIMENTAL

Sufentanil SPI analgesia

Intervention Type: 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.

Interventions

Sufentanil SPI analgesia

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.

Intervention Type: DRUG

Sufentanil ANI analgesia

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.

Intervention Type: DRUG

Sufentanil anesthesiologist analgesia

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.

Intervention Type: DRUG

Other Intervention Names

Sufentanil, SPI; Sufentanil, ANI; Sufentanil, anesthesiologist

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

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

Sponsors

University Hospital Hradec Kralove

OTHER

Sponsor Role: lead

Responsible Party

Dostalova Vlasta, MD, PhD

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vlasta Dostalova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hradec Kralove

Locations

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Countries

Czechia

Other Identifiers

201506S 38P

Identifier Type: -

Identifier Source: org_study_id