Postoperative PainNCT02765750
Postoperative Outcomes After Positive Intraoperative Messages
A study testing Intraoperative positive messages and No message in people with Postoperative Pain and Postoperative Nausea, run by 424 General Military Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea, Postoperative Vomiting
- What is being tested?
- Intraoperative positive messages and No message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic cholecystectomy.
- ASA 1-3
Who cannot join
- Hearing loss.
- Chronic use of drugs which affect the central nervous system (antidepressants, antiepileptics, opioids, benzodiazepines)
Trial locations and contacts
1 site in 1 country.
Greece1 site
424 Army General Hospital Department of Anesthesia
Thessaloniki, 56429
About this study
Official title: 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.
- Being tested
- Intraoperative positive messages, No message
- Keywords
- Emergence agitation
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative positive messagesBehavioural
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 messagesBehavioural
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 messageBehavioural
The headphones will be placed on patient's ears but no message will be played.
| Study group | Role | What they receive |
|---|---|---|
| BIS 40-60 | Experimental | Patient with intraoperative Bispectral Index (BIS) 40-60. Receives: Behavioral: Intraoperative positive messages |
| BIS 20-40 | Experimental | Patient with intraoperative Bispectral Index (BIS) 20-40. Receives: Behavioral: Intraoperative positive messages |
| Placebo | Placebo comparator | Placebo group Receives: Behavioral: No message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within an average of 15 minutes after emergence from general anesthesia.
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.
Measured: 24 hours after emergence from general anesthesia.
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.
Measured: 24 hours after emergence from general anesthesia.
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.
Measured: Within an average of 10 minutes after emergence from general anesthesia.
Postoperative nausea.
The frequency of episodes of nausea will be documented.
Measured: 24 hours after emergence from general anesthesia.
Postoperative vomiting.
The frequency of episodes of vomiting will be documented.
Measured: 24 hours after emergence from general anesthesia.
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.
Measured: 1 hour after the end of surgery.
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.
Measured: 6 hours after the end of surgery.
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.
Measured: 12 hours after the end of surgery.
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.
Measured: 24 hours after the end of surgery.
Secondary outcomes (1)
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.
Measured: 24 hours after emergence from general anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionMar 2018
Why it stopped: The primary investigator was transferred to another hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (82)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Kotsovolis, 424 General Military Hospital
- Investigators
- Georgios Kotsovolis, Dr, Principal investigator, 424 Army General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765750
- Sponsor's protocol ID
- 4659
- Status last verified
- Jun 2018
- First submitted
- 29 Apr 2016
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abdeshahi SK, Hashemipour MA, Mesgarzadeh V, Shahidi Payam A, Halaj Monfared A. Effect of hypnosis on induction of local anaesthesia, pain perception, control of haemorrhage and anxiety during extraction of third molars: a case-control study. J Craniomaxillofac Surg. 2013 Jun;41(4):310-5. doi: 10.1016/j.jcms.2012.10.009. Epub 2012 Dec 14.
PubMed 23253486Aberg KC, Albrecht E, Tartaglia EM, Farron A, Soom P, Herzog MH. Anesthesia prevents auditory perceptual learning. Anesthesiology. 2009 Nov;111(5):1010-5. doi: 10.1097/01.anes.0000363310.19041.90.
PubMed 19858871Aceto P, Valente A, Gorgoglione M, Adducci E, De Cosmo G. Relationship between awareness and middle latency auditory evoked responses during surgical anaesthesia. Br J Anaesth. 2003 May;90(5):630-5. doi: 10.1093/bja/aeg113.
PubMed 12697591Aceto P, Lai C, Perilli V, Dello Russo C, Federico B, Navarra P, Proietti R, Sollazzi L. Stress-related biomarkers of dream recall and implicit memory under anaesthesia. Anaesthesia. 2013 Nov;68(11):1141-7. doi: 10.1111/anae.12386. Epub 2013 Aug 19.
PubMed 23952901Andrade J. Does memory priming during anesthesia matter? Anesthesiology. 2005 Nov;103(5):919-20. doi: 10.1097/00000542-200511000-00002. No abstract available.
PubMed 16249662Andrade J. Investigations of hypesthesia: using anesthetics to explore relationships between consciousness, learning, and memory. Conscious Cogn. 1996 Dec;5(4):562-80. doi: 10.1006/ccog.1996.0033.
PubMed 9063616Andrade J. Learning during anaesthesia: a review. Br J Psychol. 1995 Nov;86 ( Pt 4):479-506. doi: 10.1111/j.2044-8295.1995.tb02566.x.
PubMed 8542198Andrade J, Deeprose C. Unconscious memory formation during anaesthesia. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):385-401. doi: 10.1016/j.bpa.2007.04.006.
PubMed 17900016American Society of Anesthesiologists Task Force on Intraoperative Awareness. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006 Apr;104(4):847-64. doi: 10.1097/00000542-200604000-00031. No abstract available.
PubMed 16571982Bailey AR, Jones JG. Patients' memories of events during general anaesthesia. Anaesthesia. 1997 May;52(5):460-76. doi: 10.1111/j.1365-2044.1997.133-az0134.x.
PubMed 9165967Barr G, Anderson RE, Owall A, Jakobsson JG. Being awake intermittently during propofol-induced hypnosis: a study of BIS, explicit and implicit memory. Acta Anaesthesiol Scand. 2001 Aug;45(7):834-8. doi: 10.1034/j.1399-6576.2001.045007834.x.
PubMed 11472283Bejjani G, Lequeux PY, Schmartz D, Engelman E, Barvais L. No evidence of memory processing during propofol-remifentanil target-controlled infusion anesthesia with bispectral index monitoring in cardiac surgery. J Cardiothorac Vasc Anesth. 2009 Apr;23(2):175-81. doi: 10.1053/j.jvca.2008.09.016. Epub 2008 Nov 20.
PubMed 19026570Bennett HL, Davis HS, Giannini JA. Non-verbal response to intraoperative conversation. Br J Anaesth. 1985 Feb;57(2):174-9. doi: 10.1093/bja/57.2.174.
PubMed 3970796Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Efficacy of therapeutic suggestions for improved postoperative recovery presented during general anesthesia. Anesthesiology. 1991 Nov;75(5):746-55. doi: 10.1097/00000542-199111000-00005.
PubMed 1952199Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Human learning during general anaesthesia and surgery. Br J Anaesth. 1991 Feb;66(2):170-8. doi: 10.1093/bja/66.2.170.
PubMed 1817616
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Intraoperative Positive Messages on Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT02765750
- Acronym / sponsor ID
- 4659
- Keywords
- Emergence agitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary investigator was transferred to another hospital
- Enrolment
- 5 participants (actual)
- Lead sponsor
- 424 General Military HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 9 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIS 40-60 | Experimental | Behavioral: Intraoperative positive messagesPatient with intraoperative Bispectral Index (BIS) 40-60. |
| BIS 20-40 | Experimental | Behavioral: Intraoperative positive messagesPatient with intraoperative Bispectral Index (BIS) 20-40. |
| Placebo | Placebo comparator | Behavioral: No messagePlacebo group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Laparoscopic cholecystectomy.
- ASA 1-3
Key exclusion criteria (2 listed)
- Hearing loss.
- Chronic use of drugs which affect the central nervous system (antidepressants, antiepileptics, opioids, benzodiazepines)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative positive messagesThe 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. | Behavioural | BIS 40-60 |
| Intraoperative positive messagesThe 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. | Behavioural | BIS 20-40 |
| No messageThe headphones will be placed on patient's ears but no message will be played. | Behavioural | Placebo |
Primary outcome
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.
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.
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.
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.
Postoperative nausea.
Time frame: 24 hours after emergence from general anesthesia.
The frequency of episodes of nausea will be documented.
Postoperative vomiting.
Time frame: 24 hours after emergence from general anesthesia.
The frequency of episodes of vomiting will be documented.
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.
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.
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.
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.
1 secondary outcome
Explicit memory.
Time frame: 24 hours after emergence from general anesthesia.
Results and safety
The study was stopped early (reason given: The primary investigator was transferred to another hospital). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Background: PubMed 23253486Abdeshahi SK, Hashemipour MA, Mesgarzadeh V, Shahidi Payam A, Halaj Monfared A. Effect of hypnosis on induction of local anaesthesia, pain perception, control of haemorrhage and anxiety during extraction of third molars: a case-control study. J Craniomaxillofac Surg. 2013 Jun;41(4):310-5. doi: 10.1016/j.jcms.2012.10.009. Epub 2012 Dec 14.
- Background: PubMed 19858871Aberg KC, Albrecht E, Tartaglia EM, Farron A, Soom P, Herzog MH. Anesthesia prevents auditory perceptual learning. Anesthesiology. 2009 Nov;111(5):1010-5. doi: 10.1097/01.anes.0000363310.19041.90.
- Background: PubMed 12697591Aceto P, Valente A, Gorgoglione M, Adducci E, De Cosmo G. Relationship between awareness and middle latency auditory evoked responses during surgical anaesthesia. Br J Anaesth. 2003 May;90(5):630-5. doi: 10.1093/bja/aeg113.
- Background: PubMed 23952901Aceto P, Lai C, Perilli V, Dello Russo C, Federico B, Navarra P, Proietti R, Sollazzi L. Stress-related biomarkers of dream recall and implicit memory under anaesthesia. Anaesthesia. 2013 Nov;68(11):1141-7. doi: 10.1111/anae.12386. Epub 2013 Aug 19.
- Background: PubMed 16249662Andrade J. Does memory priming during anesthesia matter? Anesthesiology. 2005 Nov;103(5):919-20. doi: 10.1097/00000542-200511000-00002. No abstract available.
- Background: PubMed 9063616Andrade J. Investigations of hypesthesia: using anesthetics to explore relationships between consciousness, learning, and memory. Conscious Cogn. 1996 Dec;5(4):562-80. doi: 10.1006/ccog.1996.0033.
- Background: PubMed 8542198Andrade J. Learning during anaesthesia: a review. Br J Psychol. 1995 Nov;86 ( Pt 4):479-506. doi: 10.1111/j.2044-8295.1995.tb02566.x.
- Background: PubMed 17900016Andrade J, Deeprose C. Unconscious memory formation during anaesthesia. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):385-401. doi: 10.1016/j.bpa.2007.04.006.
- Background: PubMed 16571982American Society of Anesthesiologists Task Force on Intraoperative Awareness. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006 Apr;104(4):847-64. doi: 10.1097/00000542-200604000-00031. No abstract available.
- Background: PubMed 9165967Bailey AR, Jones JG. Patients' memories of events during general anaesthesia. Anaesthesia. 1997 May;52(5):460-76. doi: 10.1111/j.1365-2044.1997.133-az0134.x.
- Background: PubMed 11472283Barr G, Anderson RE, Owall A, Jakobsson JG. Being awake intermittently during propofol-induced hypnosis: a study of BIS, explicit and implicit memory. Acta Anaesthesiol Scand. 2001 Aug;45(7):834-8. doi: 10.1034/j.1399-6576.2001.045007834.x.
- Background: PubMed 19026570Bejjani G, Lequeux PY, Schmartz D, Engelman E, Barvais L. No evidence of memory processing during propofol-remifentanil target-controlled infusion anesthesia with bispectral index monitoring in cardiac surgery. J Cardiothorac Vasc Anesth. 2009 Apr;23(2):175-81. doi: 10.1053/j.jvca.2008.09.016. Epub 2008 Nov 20.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
Not yet recruitingObservational study
Impact of Parasternal and Rectointercostal Blocks on Extubation Time
Postoperative Pain, Extubation Time
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Kotsovolis, Dr principal investigator
424 Army General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative positive messages and No message in people with Postoperative Pain and Postoperative Nausea, run by 424 General Military Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The primary investigator was transferred to another hospital). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity. (time frame: Within an average of 15 minutes after emergence from general anesthesia.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02765750, which also lists 82 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.