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Postoperative Outcomes After Positive Intraoperative Messages

Primary Purpose

Postoperative Pain, Postoperative Nausea, Postoperative Vomiting

Status
Terminated
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Intraoperative positive messages
Intraoperative positive messages
No message
Sponsored by
424 General Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Emergence agitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • 424 Army General Hospital Department of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BIS 40-60

BIS 20-40

Placebo

Arm Description

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

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

Placebo group

Outcomes

Primary Outcome Measures

Pain Intensity.
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.
Postoperative paracetamol consumption.
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.
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.
Emergence agitation (yes/no).
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.
Postoperative nausea.
The frequency of episodes of nausea will be documented.
Postoperative vomiting.
The frequency of episodes of vomiting will be documented.
Pain Intensity.
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.
Pain Intensity.
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.
Pain Intensity.
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.
Pain Intensity.
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.

Secondary Outcome Measures

Explicit memory.
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.

Full Information

First Posted
April 29, 2016
Last Updated
June 26, 2018
Sponsor
424 General Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02765750
Brief Title
Postoperative Outcomes After Positive Intraoperative Messages
Official Title
Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
The primary investigator was transferred to another hospital
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
424 General Military Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea, Postoperative Vomiting
Keywords
Emergence agitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIS 40-60
Arm Type
Experimental
Arm Description
Patient with intraoperative Bispectral Index (BIS) 40-60.
Arm Title
BIS 20-40
Arm Type
Experimental
Arm Description
Patient with intraoperative Bispectral Index (BIS) 20-40.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Behavioral
Intervention Name(s)
Intraoperative positive messages
Intervention Description
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
Intervention Name(s)
Intraoperative positive messages
Intervention Description
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
Intervention Name(s)
No message
Intervention Description
The headphones will be placed on patient's ears but no message will be played.
Primary Outcome Measure Information:
Title
Pain Intensity.
Description
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.
Time Frame
Within an average of 15 minutes after emergence from general anesthesia.
Title
Postoperative paracetamol consumption.
Description
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.
Time Frame
24 hours after emergence from general anesthesia.
Title
Postoperative tramadol consumption.
Description
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.
Time Frame
24 hours after emergence from general anesthesia.
Title
Emergence agitation (yes/no).
Description
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.
Time Frame
Within an average of 10 minutes after emergence from general anesthesia.
Title
Postoperative nausea.
Description
The frequency of episodes of nausea will be documented.
Time Frame
24 hours after emergence from general anesthesia.
Title
Postoperative vomiting.
Description
The frequency of episodes of vomiting will be documented.
Time Frame
24 hours after emergence from general anesthesia.
Title
Pain Intensity.
Description
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.
Time Frame
1 hour after the end of surgery.
Title
Pain Intensity.
Description
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.
Time Frame
6 hours after the end of surgery.
Title
Pain Intensity.
Description
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.
Time Frame
12 hours after the end of surgery.
Title
Pain Intensity.
Description
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.
Time Frame
24 hours after the end of surgery.
Secondary Outcome Measure Information:
Title
Explicit memory.
Description
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.
Time Frame
24 hours after emergence from general anesthesia.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Kotsovolis, Dr
Organizational Affiliation
424 Army General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
424 Army General Hospital Department of Anesthesia
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
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Postoperative Outcomes After Positive Intraoperative Messages

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