NCT06400355

Effect of Mannitol on Recovery Pattern After Orthognathic Surgery

Effect of Mannitol on Recovery Pattern After Orthognathic Surgery, a Prospective Randomized Double Blind Controlled Study.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthognathic Surgery

Interventions

Type	Name	Description
DRUG	Mannitol	in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery
DRUG	Ringer's Lactate	similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2024-05-06
• Last updated: 2024-07-23

Locations

1 site across 1 country: Egypt