Effect of Mannitol on Recovery Pattern After Orthognathic Surgery

National Cancer Institute, Egypt

Status

Active, not recruiting

Conditions

Orthognathic Surgery

Treatments

Drug: Mannitol

Drug: Ringer's Lactate

Study type

Interventional

Funder types

Other

Identifiers

NCT06400355

RC1-3-2024

Details and patient eligibility

About

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.