Postoperative Outcomes After Positive Intraoperative Messages

NCT ID: NCT02765750

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-03-31

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.

Conditions

Postoperative Pain; Postoperative Nausea; Postoperative Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

BIS 40-60

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

Group Type: EXPERIMENTAL

Intraoperative positive messages

Intervention Type: BEHAVIORAL

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.

BIS 20-40

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

Group Type: EXPERIMENTAL

Intraoperative positive messages

Intervention Type: BEHAVIORAL

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

Placebo group

Group Type: PLACEBO_COMPARATOR

No message

Intervention Type: BEHAVIORAL

The headphones will be placed on patient's ears but no message will be played.

Interventions

Intraoperative 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.

Intervention Type: BEHAVIORAL

Intraoperative 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 20-40.

Intervention Type: BEHAVIORAL

No message

The headphones will be placed on patient's ears but no message will be played.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

424 General Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Georgios Kotsovolis

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Kotsovolis, Dr

Role: PRINCIPAL_INVESTIGATOR

424 Army General Hospital

Locations

424 Army General Hospital Department of Anesthesia

Thessaloniki, , Greece

Countries

Greece

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PMID: 25735711 (View on PubMed)

Veselis RA. Memory function during anesthesia. Anesthesiology. 1999 Mar;90(3):648-50. doi: 10.1097/00000542-199903000-00003. No abstract available.

Reference Type: BACKGROUND

PMID: 10078662 (View on PubMed)

Veselis RA. Memory: a guide for anaesthetists. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):297-312. doi: 10.1016/j.bpa.2007.04.002.

Reference Type: BACKGROUND

PMID: 17900010 (View on PubMed)

Other Identifiers

4659

Identifier Type: -

Identifier Source: org_study_id