Postoperative Outcomes After Positive Intraoperative Messages

June 26, 2018 updated by: Georgios Kotsovolis, 424 General Military Hospital

Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 56429
        • 424 Army General Hospital Department of Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity.
Time Frame: 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.
Within an average of 15 minutes after emergence from general anesthesia.
Postoperative paracetamol consumption.
Time Frame: 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.
24 hours after emergence from general anesthesia.
Postoperative tramadol consumption.
Time Frame: 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.
24 hours after emergence from general anesthesia.
Emergence agitation (yes/no).
Time Frame: 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.
Within an average of 10 minutes after emergence from general anesthesia.
Postoperative nausea.
Time Frame: 24 hours after emergence from general anesthesia.
The frequency of episodes of nausea will be documented.
24 hours after emergence from general anesthesia.
Postoperative vomiting.
Time Frame: 24 hours after emergence from general anesthesia.
The frequency of episodes of vomiting will be documented.
24 hours after emergence from general anesthesia.
Pain Intensity.
Time Frame: 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.
1 hour after the end of surgery.
Pain Intensity.
Time Frame: 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.
6 hours after the end of surgery.
Pain Intensity.
Time Frame: 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.
12 hours after the end of surgery.
Pain Intensity.
Time Frame: 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.
24 hours after the end of surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explicit memory.
Time Frame: 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.
24 hours after emergence from general anesthesia.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

424 General Military Hospital

Investigators

  • Principal Investigator: Georgios Kotsovolis, Dr, 424 Army General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 29, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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