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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desflurane | Active Comparator | General Anesthesia with Desflurane |
|
| Sevoflurane | Active Comparator | General Anesthesia with Sevoflurane |
|
| Isoflurane | Active Comparator | General Anesthesia with Isoflurane |
|
| Propofol | Active Comparator | General Anesthesia with Propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desflurane | Drug | Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Ortiz, MD | Baylor College of Medicine, Dept. of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
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Recruitment from September 23, 2009 to March 9, 2010/
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| ID | Title | Description |
|---|---|---|
| FG000 | Desflurane | General Anesthesia with Desflurane |
| FG001 | Sevoflurane | General Anesthesia with Sevoflurane |
| FG002 | Isoflurane | General Anesthesia with Isoflurane |
| FG003 | Propofol | General Anesthesia with Propofol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desflurane | General Anesthesia with Desflurane |
| BG001 | Sevoflurane | General Anesthesia with Sevoflurane |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Desflurane | General Anesthesia with Desflurane |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime Ortiz, MD | Baylor College of Medicine | 713-873-2860 | jaimeo@bcm.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077335 | Desflurane |
| D000077149 | Sevoflurane |
| D007530 | Isoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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| Sevoflurane | Drug | Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane |
|
| Isoflurane | Drug | Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane |
|
| Propofol | Drug | Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion |
|
| BG002 |
| Isoflurane |
General Anesthesia with Isoflurane |
| BG003 | Propofol | General Anesthesia with Propofol |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Propofol | General Anesthesia with Propofol |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sevoflurane | General Anesthesia with Sevoflurane | 0 | 18 | 0 | 18 |
| EG002 | Isoflurane | General Anesthesia with Isoflurane | 0 | 18 | 0 | 18 |
| EG003 | Propofol | General Anesthesia with Propofol | 0 | 18 | 0 | 18 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |