ANI and SPI Guided Intraoperative Analgesia

• Sponsor: University Hospital Hradec Kralove (Other)
• Overall Status: Completed
• CT.gov ID: NCT02490540
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 14.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Sufentanil SPI analgesia; Drug: Sufentanil ANI analgesia; Drug: Sufentanil anesthesiologist analgesia	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: ANI and SPI Guided Intraoperative Analgesia in Patients Undergoing Neurosurgical Procedures Under General Anaesthesia
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anesthesiologist quided analgesia Sufentanil anesthesiologist analgesia is based on anesthesiologist decision.	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.; Other Names: Sufentanil, anesthesiologist
Experimental: ANI guided analgesia Sufentanil ANI analgesia based on ANI analgesia monitor figures.	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.; Other Names: Sufentanil, ANI
Experimental: SPI guided analgesia Sufentanil SPI analgesia is based on the SPI analgesia monitor figures.	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.; Other Names: Sufentanil, SPI

Outcome Measures

Primary Outcome Measures

1. Cortisol serum level [End of surgery]

   nmol/l

Secondary Outcome Measures

1. Time to spontaneous ventilation [From the end of anesthesia up to two hours]

   min

2. Time to extubation [From the end of anesthesia up to two hours]

   min

3. 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]

   Assessment of pain using verbal pain scale (range 0-4)

4. Pain intensity at recovery room admission [At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission]

   Assessment of pain using verbal pain scale (range 0-4)

5. Mean pain intensity at the ICU/recovery room [From the admission to the ICU or recovery room up to 2 hours postoperatively]

   Mean value of pain intensity score using verbal pain scale (range 0-4)

6. Postoperative respiratory complications [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

   Number of participants with postoperative respiratory complications

7. Sufentanil dose [From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours]

   microgramms per hour

8. Pain intensity [1st postoperative day]

   Assessment of pain using verbal pain scale (range 0-4)

9. Pain intensity [2nd postoperative day]

   Assessment of pain using verbal pain scale (range 0-4)

10. Pain intensity [3rd postoperative day]

    Assessment of pain using verbal pain scale (range 0-4)

11. Number of doses of opioid analgesics [Until the end of the 3rd postoperative day]

    The total number of doses of opioid analgesics during the 3 postoperative days

12. Number of doses of non-opioid analgesics [Until the end of the 3rd postoperative day]

    The total number of doses of non-opioid analgesics during the 3 postoperative days

13. Time to achievement of normal end-tidal CO2 value [From the end of anesthesia up to two hours]

    min

14. Length of postoperative hospital stay [From the day of surgery up to the end of hospital stay, an expected average of 2 weeks]

    days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Kralove		Czechia	50005

Sponsors and Collaborators

• University Hospital Hradec Kralove

Investigators

• Principal Investigator: Vlasta Dostalova, MD, PhD, University Hospital Hradec Kralove

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dostalova Vlasta, MD, PhD, Dr., University Hospital Hradec Kralove
• ClinicalTrials.gov Identifier: NCT02490540
• Other Study ID Numbers: 201506S 38P
• First Posted: Jul 7, 2015
• Last Update Posted: Oct 1, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Dostalova Vlasta, MD, PhD, Dr., University Hospital Hradec Kralove: opioids; analgesia; pain; anesthesia
• Additional relevant MeSH terms: Sufentanil; Dsuvia

Study Results

No Results Posted as of Oct 1, 2019