Effect of Mannitol on Recovery Pattern After Orthognathic Surgery

Orthognathic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06400355
• Other study ID #: RC1-3-2024
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2024
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthognathic Surgery

Intervention

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

Locations

Country	Name	City	State
Egypt	Benha Univesity	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt	faculty of medicine, Benha university

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to extubation	Time to extubation which is defined as time from cessation of inhalation anesthetic to extubation	1st 2 hour post-surgery
Secondary	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
Secondary	Time between anesthesia termination and discharge from PACU	Time between anesthesia termination and discharge from PACU	1st hour 2hours postoperative
Secondary	Urine output	Urine output	24 hours postoperative