Postoperative Outcomes After Positive Intraoperative Messages

Postoperative Pain Clinical Trial

Official title:

Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02765750
• Other study ID #: 4659
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: June 2018
• Source: 424 General Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Postoperative Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Greece	424 Army General Hospital Department of Anesthesia	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
424 General Military Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (82)

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* Note: There are 82 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within an average of 15 minutes after emergence from general anesthesia.
Primary	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.	24 hours after emergence from general anesthesia.
Primary	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.	24 hours after emergence from general anesthesia.
Primary	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.	Within an average of 10 minutes after emergence from general anesthesia.
Primary	Postoperative nausea.	The frequency of episodes of nausea will be documented.	24 hours after emergence from general anesthesia.
Primary	Postoperative vomiting.	The frequency of episodes of vomiting will be documented.	24 hours after emergence from general anesthesia.
Primary	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.	1 hour after the end of surgery.
Primary	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.	6 hours after the end of surgery.
Primary	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.	12 hours after the end of surgery.
Primary	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.	24 hours after the end of surgery.
Secondary	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.	24 hours after emergence from general anesthesia.