Postoperative Outcomes After Positive Intraoperative Messages

Sponsor

424 General Military Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02765750

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Postoperative Nausea Postoperative Vomiting	Behavioral: Intraoperative positive messages Behavioral: Intraoperative positive messages Behavioral: No message	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.
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 20-40.
Placebo Comparator: Placebo Placebo group	Behavioral: No message The headphones will be placed on patient's ears but no message will be played.

Arm

Intervention/Treatment

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.

Experimental: BIS 20-40

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

Behavioral: Intraoperative positive messages

Placebo Comparator: Placebo

Placebo group

Behavioral: No message

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

Outcome Measures

Primary Outcome Measures

Pain Intensity. [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.
Postoperative paracetamol consumption. [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.
Postoperative tramadol consumption. [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.
Emergence agitation (yes/no). [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.
Postoperative nausea. [24 hours after emergence from general anesthesia.]
The frequency of episodes of nausea will be documented.
Postoperative vomiting. [24 hours after emergence from general anesthesia.]
The frequency of episodes of vomiting will be documented.
Pain Intensity. [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.
Pain Intensity. [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.
Pain Intensity. [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.
Pain Intensity. [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.

Secondary Outcome Measures

Explicit memory. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	424 Army General Hospital Department of Anesthesia	Thessaloniki		Greece	56429

Sponsors and Collaborators

424 General Military Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Georgios Kotsovolis, Dr, 424 General Military Hospital

ClinicalTrials.gov Identifier:

NCT02765750

Other Study ID Numbers:

4659

First Posted:

May 9, 2016

Last Update Posted:

Jun 28, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Georgios Kotsovolis, Dr, 424 General Military Hospital

Emergence agitation

Additional relevant MeSH terms:

Vomiting

Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Jun 28, 2018