Postoperative Outcomes After Positive Intraoperative Messages

424 General Military Hospital

Status: Terminated

Conditions: Postoperative Pain; Postoperative Vomiting; Postoperative Nausea

Treatments: Behavioral: No message; Behavioral: Intraoperative positive messages

Study type: Interventional

Funder types: Other

Identifiers

NCT02765750

4659

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 3 patient groups, including a placebo group

BIS 40-60

Experimental group

Description:

Patient with intraoperative Bispectral Index (BIS) 40-60.

Treatment:

Behavioral: Intraoperative positive messages

Behavioral: Intraoperative positive messages

BIS 20-40

Experimental group

Description:

Patient with intraoperative Bispectral Index (BIS) 20-40.

Treatment:

Behavioral: Intraoperative positive messages

Behavioral: Intraoperative positive messages

Placebo

Placebo Comparator group

Description:

Placebo group

Treatment:

Behavioral: No message