To assess the effect of a bundle of non-pharmacological interventions implemented in the post-anesthesia care unit on the total serum cortisol levels after intermediate and major surgery.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum cortisol levels on the first postoperative day.
Secondary outcome
The secondary endpoints are IL-6, NLR, CRP and glucose on postoperative day 1.
Background summary
Surgical trauma and post-surgical pain induce a physiological stress response
that can be detrimental to the patient. Non-pharmacological interventions aimed
at stress reduction are known to reduce pain scores and opioid consumption. The
effect of these interventions on the surgical stress response are unknown.
Study objective
To assess the effect of a bundle of non-pharmacological interventions
implemented in the post-anesthesia care unit on the total serum cortisol levels
after intermediate and major surgery.
Study design
This is a prospective before-after study
Study burden and risks
The burden consists of:
- two questionnaires that consist of 15 questions and take a maximum of 5
minutes to complete
- one to a maximum of three extra venapunctures (depending on the specific
surgical protocol).
There is no risk associated with the stress-reducing interventions. Patients
with bronchial hyperreactivity will not be included to prevent adverse
reactions to aromatherapy.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- ASA I-III
- Ability to give oral and written informed consent
- Scheduled to undergo elective surgery with an expected minimum duration of
120 minutes
- Scheduled to undergo intermediate to major risk surgery
Exclusion criteria
- Day case surgery
- Use of neuraxial anaesthetic technique
- Chronic use of steroids
- Indication for peri-operative steroids (e.g. COPD, adrenal insufficiency)
- Bronchial hyperreactivity
- Unable to give written or oral informed consent
- Patient refusal
- Planned for post-operative ICU admission
- ASA >= 4
- Scheduled for minor risk surgery (Levels of Surgical Complexity 1 and 2)
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT05638152 |
| CCMO | NL83295.041.22 |