Clinical trial NCT02765750: Postoperative Outcomes After Positive Intraoperative Messages
Official title: Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Pain
Postoperative Nausea
Postoperative Vomiting
Keywords: Emergence agitation
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The patients scheduled for laparoscopic cholecystectomy will be allocated to 3 groups. Group A and B patients will listen to a positive message under general anesthesia. Group C patients will not listen to the message. The postoperative pain, analgesic consumption and frequency of nausea, vomiting and emergence agitation episodes will be documented and compared between the 3 groups.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy.
* ASA 1-3

Exclusion Criteria:

* Hearing loss.
* Chronic use of drugs which affect the central nervous system (antidepressants, antiepileptics, opioids, benzodiazepines)

Primary outcomes:
measure: Pain Intensity.
timeFrame: Within an average of 15 minutes after emergence from general anesthesia.
measure: Postoperative paracetamol consumption.
timeFrame: 24 hours after emergence from general anesthesia.
measure: Postoperative tramadol consumption.
timeFrame: 24 hours after emergence from general anesthesia.
measure: Emergence agitation (yes/no).
timeFrame: Within an average of 10 minutes after emergence from general anesthesia.
measure: Postoperative nausea.
timeFrame: 24 hours after emergence from general anesthesia.
measure: Postoperative vomiting.
timeFrame: 24 hours after emergence from general anesthesia.
measure: Pain Intensity.
timeFrame: 1 hour after the end of surgery.
measure: Pain Intensity.
timeFrame: 6 hours after the end of surgery.
measure: Pain Intensity.
timeFrame: 12 hours after the end of surgery.
measure: Pain Intensity.
timeFrame: 24 hours after the end of surgery.
Secondary outcomes:
measure: Explicit memory.
timeFrame: 24 hours after emergence from general anesthesia.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 424 Army General Hospital Department of Anesthesia
Study officials:
affiliation: 424 Army General Hospital
name: Georgios Kotsovolis, Dr
role: PRINCIPAL_INVESTIGATOR
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