Postoperative Outcomes After Positive Intraoperative Messages

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes

Conditions
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Postoperative Pain, Postoperative Nausea, Postoperative Vomiting

Intervention / Treatment
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* Behavioral: Intraoperative positive messages
* Behavioral: Intraoperative positive messages
* Behavioral: No message


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIS 40-60<br>Patient with intraoperative Bispectral Index (BIS) 40-60. | Behavioral: Intraoperative positive messages<br>* 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.<br>|
| Experimental: BIS 20-40<br>Patient with intraoperative Bispectral Index (BIS) 20-40. | Behavioral: Intraoperative positive messages<br>* 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 20-40.<br>|
| Placebo Comparator: Placebo<br>Placebo group | Behavioral: No message<br>* The headphones will be placed on patient's ears but no message will be played.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity. | 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. | Within an average of 15 minutes after emergence from general anesthesia. | 
| Postoperative paracetamol consumption. | 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. | 24 hours after emergence from general anesthesia. | 
| Postoperative tramadol consumption. | 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. | 24 hours after emergence from general anesthesia. | 
| Emergence agitation (yes/no). | 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. | Within an average of 10 minutes after emergence from general anesthesia. | 
| Postoperative nausea. | The frequency of episodes of nausea will be documented. | 24 hours after emergence from general anesthesia. | 
| Postoperative vomiting. | The frequency of episodes of vomiting will be documented. | 24 hours after emergence from general anesthesia. | 
| Pain Intensity. | The patients will be asked to evaluate their postoperative pain by using the 11 grade 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. | 1 hour after the end of surgery. | 
| Pain Intensity. | 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. | 6 hours after the end of surgery. | 
| Pain Intensity. | 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. | 12 hours after the end of surgery. | 
| Pain Intensity. | 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. | 24 hours after the end of surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explicit memory. | 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. | 24 hours after emergence from general anesthesia. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergence agitation