Postoperative Outcomes After Positive Intraoperative Messages

Not Applicable

Terminated

• Conditions: Postoperative Pain; Postoperative Vomiting; Postoperative Nausea
• Interventions: Behavioral: Intraoperative positive messages; Behavioral: No message

• Registration Number: NCT02765750
• Lead Sponsor: 424 General Military Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Primary Completion: 2018-02
• Study Completion: 2018-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIS 20-40	Intraoperative positive messages	Patient with intraoperative Bispectral Index (BIS) 20-40.
BIS 40-60	Intraoperative positive messages	Patient with intraoperative Bispectral Index (BIS) 40-60.
Placebo	No message	Placebo group

Primary Outcome Measures

Name	Time	Method
Postoperative nausea.	24 hours after emergence from general anesthesia.	The frequency of episodes of nausea 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.
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.
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 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.
Postoperative vomiting.	24 hours after emergence from general anesthesia.	The frequency of episodes of vomiting will be documented.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

424 Army General Hospital Department of Anesthesia; 🇬🇷 Thessaloniki, Greece