Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06400355

Effect of Mannitol on Recovery Pattern After Orthognathic Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha Univesity

Cairo, 11796, Egypt

About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mannitol

Drug

in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery

Ringer's Lactate

Drug

similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery.

Primary outcomes

  1. Time to extubation

    Time frame: 1st 2 hour post-surgery

    Time to extubation which is defined as time from cessation of inhalation anesthetic to extubation

Secondary outcomes

  1. Quality of Recovery-15 (QoR-15)

    Time frame: 1st 2 hour postoperative

    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).

  2. Time between anesthesia termination and discharge from PACU

    Time frame: 1st hour 2hours postoperative

    Time between anesthesia termination and discharge from PACU

  3. Urine output

    Time frame: 24 hours postoperative

    Urine output

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Collaborators

  • faculty of medicine, Benha university

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 6, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.