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Postoperative Outcomes After Positive Intraoperative Messages

NCT02765750 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-06-28

No results posted yet for this study

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

Interventions

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 40-60.

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.

BEHAVIORAL

No message

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

Sponsors & Collaborators

  • 424 General Military Hospital

    lead OTHER

Principal Investigators

  • Georgios Kotsovolis, Dr · 424 Army General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-02-28
Completion
2018-03-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02765750 on ClinicalTrials.gov