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| Name | Class |
|---|---|
| Faculdade de Ciências Médicas da Santa Casa de São Paulo | OTHER |
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The use of opioid during surgery can cause side effects and may delay hospital discharge. Some studies have shown balanced sparing opioid anesthesia can optimize the side effects and and the time of discharge. In this compared controlled randomized study the aim is to evaluate the intraoperative and postoperative pain, hemodynamic effects, nausea/vomiting, postoperative ileus, sedation, urinary retention, time of discharge PACU Post anesthesia care unit and hospital.
Patients under laparoscopic cholecystectomy has moderate to severe pain. This study will compare intraoperative hemodynamic parameters under two techniques of general anesthesia: The primary outcome pain was used for planning the sample size of participants and considered a variation of 3 points on VAS (Visual analogic scale of pain). The secondaries outcomes nausea/vomiting, sedation, ileus paralytics, urinary retention, time of discharge (PACU) and hospital stay, and patient satisfaction will be recorded and analyzed.
the patients will be allocated from randomized program in one of the two arms.
At the end of procedure both groups will receive dexamethasone, ranitidine
, ondansetron, keterolac IV and local infiltration of bupivacaine on trocar wounds as multimodal analgesia.
General anesthesia opioid free seems to have less side effects than the general anesthesia based on opioid this study will compare it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GF general free | Experimental | pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h |
|
| GBal general balanced | Active Comparator | pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexter ketamine | Drug | multimodal anesthesia without opioids ketamine as induction drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | will be asked pain at rest and movement and cough using the analog verbal scale of pain | 60min after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| nausea/ vomiting | will be asked yes or not and how many times | 12, 24 and 36 hours after surgery |
| Paralytic ileus | will be access with ultrasound movement of intestine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| marcelo v perez, PhD | Faculdade De Ciencias Medicas da Santa Casa de Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Ciências Médicas da Santa Casa de São Paulo | São Paulo | São Paulo | 01221-020 | Brazil | ||
| Faculdade de Ciências Médicas da Santa Casa de São Paulo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16571981 | Background | Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. doi: 10.1097/00000542-200604000-00030. | |
| 22584558 | Background | De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 13, 2017 | |
| Reset | Oct 27, 2017 |
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| Lidocaine Hydrochloride | Drug | continuous infusion intravenous |
|
|
| Fentanyl Hydrochloride | Drug | intravenous |
|
|
| Clonidine Hydrochloride | Drug | clonidine intravenous pre induction |
|
|
| Midazolam Hydrochloride | Drug | premedication |
|
| Isoflurane Volatile Liquid | Drug | maintenance of general anesthesia |
|
|
| Rocuronium Injectable Solution | Drug | induction of general anesthesia |
|
|
| Propofol 1 % Injectable Suspension | Drug | induction of general anesthesia |
|
|
| Dexamethasone-21-Sulfobenzoate, Sodium Salt | Drug | at the end of the procedure 4mg IV |
|
| Ranitidine Hydrochloride | Drug | at the end of the procedure |
|
| Ondansetron Hydrochloride | Drug | at the end of the procedure |
|
|
| Ketorolac Injectable Solution | Drug | at the of the procedure |
|
|
| Bupivacaine Hydrochloride | Drug | at the end of the procedure for infiltration of trocar wounds |
|
|
| 12, 24 and 36 hours after surgery |
| first analgesic rescue requirement | the first analgesic given at PACU when the patient asked for it | 12 hours after the surgery |
| pruritus | yes or no, mild, moderate to serve | 12, 24 , 36 hours after surgery |
| sedation | will be use the Ramasay scale | 12, 24 and 26 hours after surgery |
| time of discharge of PACU | time when the patient will transfer to ward after the surgery | 12 hour after the surgery |
| Hemodynamics effects | mean arterial pressure | intraoperative |
| weight | measure in kilogram | Baseline |
| height | measure in cm | Baseline |
| gender | male or female | Baseline |
| saturation of o2 | oximetry | intraoperative |
| ETCO2 | capnography | intraoperative |
| heart rate | heart rate | intraoperative |
| pain | will be asked pain at rest and movement and cough using the analog verbal scale of pain | 12, 24 and 36 hours after the procedure |
| São Paulo |
| São Paulo |
| 01333000 |
| Brazil |
| 17959952 | Result | Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM, Carli F. Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg. 2007 Nov;105(5):1255-62, table of contents. doi: 10.1213/01.ane.0000282822.07437.02. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 13, 2017 | Oct 27, 2017 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009325 | Nausea |
| D014839 | Vomiting |
| D045823 | Ileus |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008012 | Lidocaine |
| D005283 | Fentanyl |
| D003000 | Clonidine |
| D008874 | Midazolam |
| D007530 | Isoflurane |
| D000077123 | Rocuronium |
| D015742 | Propofol |
| C079704 | dexamethasone-21-sulfobenzoate |
| D011899 | Ranitidine |
| D017294 | Ondansetron |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D005663 | Furans |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
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