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| Name | Class |
|---|---|
| faculty of medicine, Benha university | UNKNOWN |
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The aim of this study is to test, whether mannitol infusion in different doses will affect recovery pattern? the investigators hypothesized that infusion of mannitol in doses of 0.5 gm/kg before recovery from anesthesia after orthognathic surgery shortens patients' recovery time, and improves recovery quality, as well as postoperative cognitive function better.
The aim of this study is to test, whether mannitol infusion in different doses will affect recovery pattern? the investigators hypothesized that infusion of mannitol in doses of 0.5 gm/kg before recovery from anesthesia after orthognathic surgery shortens patients' recovery time, and improves recovery quality, as well as postoperative cognitive function better Methodology This prospective randomized double blinded study will be applied on patients scheduled for orthognathic surgeries as Temporo-mandibular joint procedures, Le Forte Ι 0r II osteotomy, bimax or maxillectomy after ethical committee approval.
The selected patients were randomly allocated into two groups each containing 30 patients:
Anaesthetic technique:
For all Patients, atropine sulphate 0.015 mg/kg intramuscular (IM) as anti-sialgogue together with dexamethasone 8 mg. Hydrocortisone 100 mg and ranitidine 50 mg, will be given IV as pre-medications 15-30 minutes before induction of anaesthesia patient will be transferred to the operating theatre where ASA-basic monitors will be applied to the patient (pulse-oxymitery, non-invasive blood pressure, ECG 3-Leads and capnography).
Induction of anesthesia:
Regular IV induction will be applied for patients with normal mouth opening where difficult intubation is not suspected: fentanyl 2 μg/kg IV, propofol 1 mg/kg IV, atracurium 0.5 mg/kg IV then nasotracheal intubation with armored tube of appropriate size.
Patients with difficult mouth opening will undergo awake fiberoptic intubation. Anesthesia will be maintained by 100% O2 + 1-1.5 MAC isoflurane Thirty minutes before the end of surgery patients will receive an IV solution which is either mannitol 0.5 gm/kg or lactated Ringer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group M | Active Comparator | in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery. |
|
| Group C | Active Comparator | similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mannitol | Drug | in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation | Time to extubation which is defined as time from cessation of inhalation anesthetic to extubation | 1st 2 hour post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-15 (QoR-15) | A patient-reported outcome measure measuring quality of recovery after surgery and anaesthesia. It is a 15-point questionnaire with an 11-point numerical rating scale (for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items the scoring was reversed; maximum score 150). | 1st 2 hour postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Soliman | National Cancer Institute Cairo university | Principal Investigator |
| Mahmoud M kaml | National Cancer Institute Cairo university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha Univesity | Cairo | 11796 | Egypt |
Till publication
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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The aim of this study is to test, whether mannitol infusion in will affect recovery pattern?
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The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
| Ringer's Lactate | Drug | similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery. |
|
| Time between anesthesia termination and discharge from PACU | Time between anesthesia termination and discharge from PACU | 1st hour 2hours postoperative |
| Urine output | Urine output | 24 hours postoperative |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |