Postoperative PainNCT00983918
Pain After Laparoscopic Cholecystectomy
A study testing Desflurane, Sevoflurane and Isoflurane in people with Postoperative Pain, run by Baylor College of Medicine at 1 site in United States.
Trial summary
To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Desflurane, Sevoflurane and Isoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient ages 18-64
- American Society of Anesthesiology Physical Status I, II or III
- Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital
Who cannot join
- Open cholecystectomy - excluded due to increased levels of pain in open procedures
- Scheduled for ambulatory surgery
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
- Allergy to any of the study medications or anesthetic agents
- Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
- Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
- Patient or surgeon refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain After Laparoscopic Cholecystectomy After Anesthesia With Isoflurane, Desflurane, Sevoflurane or Propofol
To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane.
PURPOSE
To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.
- Conditions
- Postoperative Pain
- Being tested
- Desflurane, Sevoflurane, Isoflurane, Propofol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane
SevofluraneDrug
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane
IsofluraneDrug
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane
PropofolDrug
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Active comparator | General Anesthesia with Desflurane Receives: Drug: Desflurane |
| Sevoflurane | Active comparator | General Anesthesia with Sevoflurane Receives: Drug: Sevoflurane |
| Isoflurane | Active comparator | General Anesthesia with Isoflurane Receives: Drug: Isoflurane |
| Propofol | Active comparator | General Anesthesia with Propofol Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measured on Verbal Scale of 0-10
Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ortiz, Baylor College of Medicine
- Investigators
- Jaime Ortiz, MD, Principal investigator, Baylor College of Medicine, Dept. of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983918
- Sponsor's protocol ID
- H-24815
- Status last verified
- Jan 2019
- First submitted
- 22 Sep 2009
- Last updated
- 1 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Laparoscopic Cholecystectomy After Anesthesia With Isoflurane, Desflurane, Sevoflurane or Propofol
- ClinicalTrials.gov ID
- NCT00983918
- Acronym / sponsor ID
- H-24815
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Posted 11 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane.
PURPOSE
To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Active comparator | Drug: DesfluraneGeneral Anesthesia with Desflurane |
| Sevoflurane | Active comparator | Drug: SevofluraneGeneral Anesthesia with Sevoflurane |
| Isoflurane | Active comparator | Drug: IsofluraneGeneral Anesthesia with Isoflurane |
| Propofol | Active comparator | Drug: PropofolGeneral Anesthesia with Propofol |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient ages 18-64
- American Society of Anesthesiology Physical Status I, II or III
- Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital
Key exclusion criteria (7 listed)
- Open cholecystectomy - excluded due to increased levels of pain in open procedures
- Scheduled for ambulatory surgery
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
- Allergy to any of the study medications or anesthetic agents
- Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
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 |
|---|---|---|
| DesfluranePatient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane | Drug | Desflurane |
| SevofluranePatient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane | Drug | Sevoflurane |
| IsofluranePatient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane | Drug | Isoflurane |
| PropofolPatient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion | Drug | Propofol |
Primary outcome
Pain Measured on Verbal Scale of 0-10
Time frame: 24 hours
Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jaime Ortiz, MD principal investigator
Baylor College of Medicine, Dept. of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane, Sevoflurane and Isoflurane in people with Postoperative Pain, run by Baylor College of Medicine at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 1 Feb 2019. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Measured on Verbal Scale of 0-10 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2019.