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ID
Source
Brief title
Health condition
Surgical patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative pain score
Secondary outcome
(!) Postoperative opioid consumption as measured in the first 90 min of PACU stay
(2) Fentanyl use during anesthesia;
(3) Sevoflurane consumption during anesthesia;
(4) Inadequate hemodynamic events, see Table 1;
(5) Time between reversal of neuromuscular block and extubation/eyes open;
(6) Occurrence of awareness;
(7) Anesthesia and surgery times/PACU stay time.
Background summary
Inadequate (under-dosing) as well as excessive (overdosing) levels of analgesia and anesthesia are associated with poor patient outcome. Currently, the analgesic component of anesthesia is steered using traditional indices, such as heart rate and blood pressure. However, the use of these indirect parameters for nociception is inaccurate and often results in under- or overdosing of anesthetics. Recently a newly developed index, the Nociceptive Level (NOL) index was validated and showed superiority over heart rate and blood pressure in relation to intense and mild nociceptive stimuli. In this study we will assess the effect of NOL guided anesthesisa (fentanyl/sevoflurane/rocuronium) on postoperative pain and opioid consumption.
Objective
To guide the analgesic component of anesthesia using the NOL index in ASA 1-3 patients under general anesthesia for elective abdominal surgery.
Study design
A randomized, double blinded, controlled trial in which standard care anesthesia and NoL-guided anesthesia will be compared in ASA I-III patients requiring elective abdominal surgery under general anesthesia.
Study population
50 ASA 1-3 patients undergoing elective open abdominal surgery or laparoscopic/ robot-assisted abdominal surgery will.
Main end-points
1. Postoperative pain
Secondary end-points
1. Postoperative opioid consumption
2. Opioid and sevoflurane consumption in total dose and dose/min; and
3. Incidence (number of episodes) of inadequate anesthesia (as derived from heart rate, blood pressure, BIS values)
Study objective
We hypothesize that, compared with standard management, NoL-guided anesthesia will lead to reduced postoperative pain scores, and during anesthesia to increased hemodynamic stability.
Study design
Start June 28, 2019 - End June 28, 2020
Intervention
This is a double blind, randomized controlled superiority trial in which NOL-guided anesthesia will be compared to standard of care in ASA 1-3 patients undergoing elective open abdominal surgery or laparoscopic assisted abdominal surgery.
Inclusion criteria
1. Age: 18 years and older;
2. ASA I-II-III
3. Elective open abdominal surgery or robot/laparoscopic assisted abdominal surgery.
Exclusion criteria
1. Unable to give written informed consent;
2. Use of epidural analgesia or local anesthesia (eg. transversus abdominal plain block, TAP block)
3. Non-elective surgery
4. Pregnancy/lactation.
5. BMI > 35 kg/m2;
6. Uncontrolled preoperative hypo- or hypertension (Mean arterial pressure < 60 mmHg or systolic blood pressure > 160 mmHg)
7. Preoperative Heart rate < 45/min or > 90/min;
8. Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures);
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7845 |
| Other | METC-Leiden Den Haag Delft : METC-LDD P19.012 |