Clinical trial NCT06400355: Effect of Mannitol on Recovery Pattern After Orthognathic Surgery
Official title: Effect of Mannitol on Recovery Pattern After Orthognathic Surgery, a Prospective Randomized Double Blind Controlled Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthognathic Surgery
Keywords: Mannitol
Recovery
Orthognathic Surgery
mandiblular fracture
maxillary protrusion
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
Collaborators: name: faculty of medicine, Benha university
First posted: 2024-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The aim of this study is to test, whether mannitol infusion in will affect recovery pattern?
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to extubation
timeFrame: 1st 2 hour post-surgery
Secondary outcomes:
measure: Quality of Recovery-15 (QoR-15)
timeFrame: 1st 2 hour postoperative
measure: Time between anesthesia termination and discharge from PACU
timeFrame: 1st hour 2hours postoperative
measure: Urine output
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Benha Univesity
Study officials:
affiliation: National Cancer Institute Cairo university
name: Ahmed M Soliman
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute Cairo university
name: Mahmoud M kaml
role: PRINCIPAL_INVESTIGATOR
References: