Clinical trial NCT02490540: ANI and SPI Guided Intraoperative Analgesia
Official title: ANI and SPI Guided Intraoperative Analgesia in Patients Undergoing Neurosurgical Procedures Under General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: opioids
analgesia
pain
anesthesia
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Cortisol serum level
timeFrame: End of surgery
Secondary outcomes:
measure: Time to spontaneous ventilation
timeFrame: From the end of anesthesia up to two hours
measure: Time to extubation
timeFrame: From the end of anesthesia up to two hours
measure: Pain intensity at the time of departure from the operating theater
timeFrame: At the time of departure from the operating room, up to 30 min from the end of anesthesia
measure: Pain intensity at recovery room admission
timeFrame: At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission
measure: Mean pain intensity at the ICU/recovery room
timeFrame: From the admission to the ICU or recovery room up to 2 hours postoperatively
measure: Postoperative respiratory complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Sufentanil dose
timeFrame: From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours
measure: Pain intensity
timeFrame: 1st postoperative day
measure: Pain intensity
timeFrame: 2nd postoperative day
measure: Pain intensity
timeFrame: 3rd postoperative day
measure: Number of doses of opioid analgesics
timeFrame: Until the end of the 3rd postoperative day
measure: Number of doses of non-opioid analgesics
timeFrame: Until the end of the 3rd postoperative day
measure: Time to achievement of normal end-tidal CO2 value
timeFrame: From the end of anesthesia up to two hours
measure: Length of postoperative hospital stay
timeFrame: From the day of surgery up to the end of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vlasta Dostalova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: