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| Name | Class |
|---|---|
| Haseki Training and Research Hospital | OTHER |
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The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.
Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.
Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.
Material and methods : Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia : abdominal discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory blockade, respiratory depression. We compare between two group; shoulder pain, postoperative complications, pain score, duration of operation time and length of hospital stay.
Fifty patients will select prospectively for LC, under low pressure (10 mm Hg) pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with 0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Active Comparator | Laparoscopic cholecystectomy in General Anesthesia |
|
| group 2 | Active Comparator | Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined anesthesia | Procedure | Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Operation | group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes | up to 2 hours |
| Post-operative Shoulder Pain | Group 1 and Group 2 Post-operative shoulder pain | from end of the operation to postoperative 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Anaesthesia | Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23 | up to 2 hours |
| Post-operative Abdominal Pain 2nd Hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Turgut Donmez, operator MD | Lutfiye NBGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lutfiye NBGH | Istanbul | 34300 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22686181 | Background | Bessa SS, Katri KM, Abdel-Salam WN, El-Kayal el-SA, Tawfik TA. Spinal versus general anesthesia for day-case laparoscopic cholecystectomy: a prospective randomized study. J Laparoendosc Adv Surg Tech A. 2012 Jul-Aug;22(6):550-5. doi: 10.1089/lap.2012.0110. Epub 2012 Jun 11. |
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medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Laparoscopic cholecystectomy in General Anesthesia |
| FG001 | Group 2 | Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy |
| BG001 | Group 2 | Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Duration of Operation | group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes | All patients have gall bladder disease who are between 18-90 years old. | Posted | Mean | Standard Deviation | minutes | up to 2 hours |
|
December 2014-may 2015
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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 | Group 1 | Laparoscopic cholecystectomy in General Anesthesia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mean vascular injury | Injury, poisoning and procedural complications | vascular injury | Non-systematic Assessment | main vascular injury did not occur in both groups |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
one patients had dural injury. Because of this that patient had released.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Turgut Donmez | Lutfiye NBGH | 00905347400967 | surgeont73@hotmail.com |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| general anesthesia | Procedure | General anesthesia for laparoscopic cholecystectomy |
|
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. |
| pain at postoperative 2nd hour |
| Post-operative Abdominal Pain 4th Hour | VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 4th hour |
| Post-operative Abdominal Pain 6th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 6th hour |
| Post-operative Abdominal Pain 12th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 12th hour |
| Post-operative Abdominal Pain 24th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 24th hour |
| Intra-operative Shoulder Pain | Group 1 and Group 2 Intra-operative shoulder pain | during operation time, up to 2 hours |
| Urinary Retention | Group 1 and Group 2 Urinary retention | from end of the operation to postoperative 1 day |
| Nausea/Vomiting | Group 1 and group 2 nausea/vomiting | from end of the operation to postoperative 1 day |
| Headache | Group 1 and Group 2 Headache | from end of the operation to postoperative 3 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | BMI:Body Mass Index | Median | Standard Deviation | kg/m^2 |
|
| ASA (American Society of Anesthesiologists scores) | The ASA score is a subjective assessment of a patient's overall health that is based on five classes (I to V). I- Patient is a completely healthy fit patient. II- Patient has mild systemic disease. III-Patient has severe systemic disease that is not incapacitating. IV-Patient has incapacitating disease that is a constant threat to life. V-A moribund patient who is not expected to live 24 hour with or without surgery. | Median | Full Range | units on a scale |
|
|
|
| Secondary | Duration of Anaesthesia | Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23 | All patients have gall bladder disease who are between 18-90 years old. | Posted | Mean | Standard Deviation | minutes | up to 2 hours |
|
|
|
| Secondary | Post-operative Abdominal Pain 2nd Hour | VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | All patients have gall bladder disease who are between 18-90 years old. | Posted | Least Squares Mean | Standard Deviation | units on a scale | pain at postoperative 2nd hour |
|
|
|
| Secondary | Post-operative Abdominal Pain 4th Hour | VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | All patients have gall bladder disease who are between 18-90 years old. | Posted | Least Squares Mean | Standard Deviation | units on a scale | pain at postoperative 4th hour |
|
|
|
| Secondary | Post-operative Abdominal Pain 6th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | All patients have gall bladder disease who are between 18-90 years old. | Posted | Least Squares Mean | Standard Deviation | units on a scale | pain at postoperative 6th hour |
|
|
|
| Secondary | Post-operative Abdominal Pain 12th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | All patients have gall bladder disease who are between 18-90 years old. | Posted | Least Squares Mean | Standard Deviation | units on a scale | pain at postoperative 12th hour |
|
|
|
| Secondary | Post-operative Abdominal Pain 24th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | All patients have gall bladder disease who are between 18-90 years old. | Posted | Least Squares Mean | Standard Deviation | units on a scale | pain at postoperative 24th hour |
|
|
|
| Primary | Post-operative Shoulder Pain | Group 1 and Group 2 Post-operative shoulder pain | All patients have gall bladder disease who are between 18-90 years old | Posted | Number | participants | from end of the operation to postoperative 3 days |
|
|
|
| Secondary | Intra-operative Shoulder Pain | Group 1 and Group 2 Intra-operative shoulder pain | All patients have gall bladder disease who are between 18-90 years old. | Posted | Number | participants | during operation time, up to 2 hours |
|
|
|
| Secondary | Urinary Retention | Group 1 and Group 2 Urinary retention | All patients have gall bladder disease who are between 18-90 years old | Posted | Number | participants | from end of the operation to postoperative 1 day |
|
|
|
| Secondary | Nausea/Vomiting | Group 1 and group 2 nausea/vomiting | All patients have gall bladder disease who are between 18-90 years old. | Posted | Number | participants | from end of the operation to postoperative 1 day |
|
|
|
| Secondary | Headache | Group 1 and Group 2 Headache | All patients have gall bladder disease who are between 18-90 years old. | Posted | Number | participants | from end of the operation to postoperative 3 days |
|
|
|
| 0 |
| 25 |
| 21 |
| 25 |
| EG001 | Group 2 | Laparoscopic cholecystectomy in combined spinal epidural anaesthesia | 0 | 24 | 16 | 24 |
|
| embolism | Blood and lymphatic system disorders | embolism | Non-systematic Assessment | embolism did not occur in both groups |
|
| choledocal injury | Injury, poisoning and procedural complications | choledocal injury | Non-systematic Assessment | choledocal injury did not occur in both groups |
|
| post-operative shoulder pain | Nervous system disorders | pain | Non-systematic Assessment | post-operative shoulder pain;in both groups |
|
| Urinary retansion | Renal and urinary disorders | Non-systematic Assessment | Urinary retention;from end of the operation to postoperative 1 day |
|
| Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment | Nausea/vomiting;intraoperative ve postoperative |
|
| Headache | Nervous system disorders | headache | Non-systematic Assessment | Headache;from end of the operation to postoperative 3 days |
|
| intra-operative shoulder pain | Nervous system disorders | Non-systematic Assessment | intra-operative shoulder pain:during operation time, up to 2 hours |
|
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