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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02765750
Other study ID # 4659
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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 allClick 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.
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