Postoperative Nausea, Postoperative Pain, Postoperative Vomiting
Conditions
Keywords
Emergence agitation
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.
Interventions
BEHAVIORALIntraoperative positive messages
The message You are in the operating room. Everything is going very well. When you wake up you will be very calm, you will not feel pain and you will not have nausea will be played in greek language by headphones to the patient when the Bispectral Index (BIS) is 40-60.
BEHAVIORALNo message
The headphones will be placed on patient's ears but no message will be played.
Sponsors
424 General Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative tramadol consumption. | 24 hours after emergence from general anesthesia. | If the administration of paracetamol doesn't relieve postoperative pain and the patients continues to ask for analgesia, 100mg tramadol will be administered. The frequency of tramadol administration will be documented. |
| Pain Intensity. | Within an average of 15 minutes after emergence from general anesthesia. | The patients will be asked to evaluate their postoperative pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain). Pain will be evaluated in supine position, after cough and after change of position from supine to standing. |
| Postoperative paracetamol consumption. | 24 hours after emergence from general anesthesia. | The patients will be instructed to ask for analgesics as needed. When rescue analgesia is required 1000mg paracetamol will be administered. The frequency of paracetamol administration will be documented. |
| Postoperative vomiting. | 24 hours after emergence from general anesthesia. | The frequency of episodes of vomiting will be documented. |
| Emergence agitation (yes/no). | Within an average of 10 minutes after emergence from general anesthesia. | The patients' mental status will be evaluated with the 7grade Riker's Agitation-Sedation Scale. If the patient has a score of 5 or greater he will be documented as a case of emergence agitation. |
| Postoperative nausea. | 24 hours after emergence from general anesthesia. | The frequency of episodes of nausea will be documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Explicit memory. | 24 hours after emergence from general anesthesia. | The patient will be asked to answer the modified Brice questionnaire in order to investigate for explicit memory of the intraoperative message or other events. |
Countries
Greece
Outcome results
None listed