Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia

Hypovolemia Clinical Trial

Official title:

Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193412
• Other study ID #: 2013_13
• Secondary ID: 2013-A01645-40
• Status: Completed
• Phase: N/A
• Start date: January 4, 2015
• Est. completion date: October 3, 2017

Study information

• Verified date: October 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.

Description:

In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its sensitivity to detect noxious stimulus was studied in several studies. However, its specificity is not established in particular in the presence of factors influencing autonomic nervous system other than analgesia/nociception balance. In the context of anaesthesia, one of the most relevant factor is hypovolemia. This study aims to assess the effect of blood volume variations on ANI under general anaesthesia, independently of analgesia/nociception balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects blood volume status, will be induced by changes of operating table slope, from head-down tilt (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations of SVR will be attested by changes in the arterial pulse pressure variation, a well-established indice of preload responsiveness in the mechanically ventilated anaesthetized patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 3, 2017
• Est. primary completion date: October 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• neurosurgical operation requiring invasive monitoring of arterial blood pressure

Exclusion Criteria:

• pacemaker, arrhythmia

• chronic medication with beta blocker

• possible disorder of autonomic nervous system: diabetes, alcoholism, chronic pain

• anticholinergic drug administration before measures

• intracranial hypertension

• no social security coverage

• pregnancy

Related Conditions & MeSH terms

• Hypovolemia
• Nociceptive Pain
• Somatic Pain

Intervention

Procedure:
• noxious stimulus
standardized noxious stimulus with tetanic stimulation
• change in operating table slope: head-down tilt position
-30°
• change in operating table slope: head-up tilt position
+30°

Locations

Country	Name	City	State
France	University Hospital	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position	Position -20° to +20°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Secondary	change in ANI between horizontal position and head-down/head up tilt position	Position 0° to -20° Position +20° to 0°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Secondary	change in pulse pressure variation between head-down tilt position and head-up tilt position	Position -20° to +20°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Secondary	change in ANI induced by standardized noxious stimulus (tetanic stimulation)	ANI measurement following tetanus	during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)
Secondary	variations of low frequency variability of arterial blood pressure	Position 0° to -20° Position -20° to +20° Position +20° to 0°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Secondary	change in pulse pressure variation between horizontal position and head-down/head up tilt position	Position 0° to -20° Position +20° to 0°	during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)