ANI and SPI Guided Intraoperative Analgesia

Anesthesia Clinical Trial

Official title:

ANI and SPI Guided Intraoperative Analgesia in Patients Undergoing Neurosurgical Procedures Under General Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490540
• Other study ID #: 201506S 38P
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2019
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol serum level	nmol/l	End of surgery
Secondary	Time to spontaneous ventilation	min	From the end of anesthesia up to two hours
Secondary	Time to extubation	min	From the end of anesthesia up to two hours
Secondary	Pain intensity at the time of departure from the operating theater	Assessment of pain using verbal pain scale (range 0-4)	At the time of departure from the operating room, up to 30 min from the end of anesthesia
Secondary	Pain intensity at recovery room admission	Assessment of pain using verbal pain scale (range 0-4)	At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission
Secondary	Mean pain intensity at the ICU/recovery room	Mean value of pain intensity score using verbal pain scale (range 0-4)	From the admission to the ICU or recovery room up to 2 hours postoperatively
Secondary	Postoperative respiratory complications	Number of participants with postoperative respiratory complications	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Sufentanil dose	microgramms per hour	From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours
Secondary	Pain intensity	Assessment of pain using verbal pain scale (range 0-4)	1st postoperative day
Secondary	Pain intensity	Assessment of pain using verbal pain scale (range 0-4)	2nd postoperative day
Secondary	Pain intensity	Assessment of pain using verbal pain scale (range 0-4)	3rd postoperative day
Secondary	Number of doses of opioid analgesics	The total number of doses of opioid analgesics during the 3 postoperative days	Until the end of the 3rd postoperative day
Secondary	Number of doses of non-opioid analgesics	The total number of doses of non-opioid analgesics during the 3 postoperative days	Until the end of the 3rd postoperative day
Secondary	Time to achievement of normal end-tidal CO2 value	min	From the end of anesthesia up to two hours
Secondary	Length of postoperative hospital stay	days	From the day of surgery up to the end of hospital stay, an expected average of 2 weeks