Postoperative Outcomes After Positive Intraoperative Messages

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Keywords

Abstract

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.

Dates

Last Verified:	05/31/2018
First Submitted:	04/28/2016
Estimated Enrollment Submitted:	05/05/2016
First Posted:	05/08/2016
Last Update Submitted:	06/25/2018
Last Update Posted:	06/27/2018
Actual Study Start Date:	02/29/2016
Estimated Primary Completion Date:	01/31/2018
Estimated Study Completion Date:	02/28/2018

Condition or disease

Postoperative Pain

Postoperative Nausea

Postoperative Vomiting

Intervention/treatment

Behavioral: BIS 40-60

Behavioral: BIS 20-40

Behavioral: Placebo

Phase

Arm Groups

Arm	Intervention/treatment
Experimental: BIS 40-60 Patient with intraoperative Bispectral Index (BIS) 40-60.	Behavioral: BIS 40-60 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.
Experimental: BIS 20-40 Patient with intraoperative Bispectral Index (BIS) 20-40.	Behavioral: BIS 20-40 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.
Placebo Comparator: Placebo Placebo group	Behavioral: Placebo The headphones will be placed on patient's ears but no message will be played.

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
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)

Outcome

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. Postoperative nausea. [24 hours after emergence from general anesthesia.]

The frequency of episodes of nausea will be documented.

6. Postoperative vomiting. [24 hours after emergence from general anesthesia.]

The frequency of episodes of vomiting will be documented.

7. Pain Intensity. [1 hour after the end of surgery.]

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.

8. Pain Intensity. [6 hours after the end of surgery.]

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.

9. Pain Intensity. [12 hours after the end of surgery.]

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.

10. Pain Intensity. [24 hours after the end of surgery.]

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.

Secondary Outcome Measures

1. 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.

Postoperative Outcomes After Positive Intraoperative Messages

Keywords

nausea

vomiting

emergence delirium

analgesic

Abstract

Dates

Condition or disease

Intervention/treatment

Phase

Arm Groups

Eligibility Criteria

Outcome

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