Orthognathic Surgery
Conditions
Keywords
Mannitol, Recovery, Orthognathic Surgery, mandiblular fracture, maxillary protrusion
Brief summary
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.
Detailed description
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: * Group M: in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery * Group C: similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery 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.
Interventions
DRUGMannitol
in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery
DRUGRinger's Lactate
similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery.
Sponsors
faculty of medicine, Benha university
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
The aim of this study is to test, whether mannitol infusion in will affect recovery pattern?
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-65 years * ASA status I and II patient. * No contraindication to use of mannitol.
Exclusion criteria
* ASA III and IV status * Extreme of age: paediatric and geriatric patients * Severe cardio respiratory, rheumatological or endocrinal disorders * Pregnancy and lactation * Contraindications to the use of mannitol, e.g. serum osmolality \> 330, renal failure systemic hypertension, proved intra-cranial brain haemorrhage or sub-dural haematoma and hypotension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to extubation | 1st 2 hour post-surgery | Time to extubation which is defined as time from cessation of inhalation anesthetic to extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-15 (QoR-15) | 1st 2 hour postoperative | 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). |
| Time between anesthesia termination and discharge from PACU | 1st hour 2hours postoperative | Time between anesthesia termination and discharge from PACU |
| Urine output | 24 hours postoperative | Urine output |
Countries
Egypt
Outcome results
None listed