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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Orthognathic Surgery
• Intervention / Treatment: Drug: Mannitol; Drug: Ringer's Lactate

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Benha Univesity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group M; in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery.	Drug: Mannitol; in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery
Active Comparator: Group C; similar volume of the infused mannitol but of lactated Ringer will be given 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to extubation	Time to extubation which is defined as time from cessation of inhalation anesthetic to extubation	1st 2 hour post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time between anesthesia termination and discharge from PACU	Time between anesthesia termination and discharge from PACU	1st hour 2hours postoperative
Urine output	Urine output	24 hours postoperative

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Collaborators: faculty of medicine, Benha university
• Investigators: Principal Investigator: Ahmed M Soliman, National Cancer Institute Cairo University; Principal Investigator: Mahmoud M kaml, National Cancer Institute Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 21, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Recovery; Orthognathic Surgery; Mannitol; mandiblular fracture; maxillary protrusion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: RC1-3-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Till publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No