Clinical trial

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

Name
RC1-3-2024
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-06-01
Trial end
2024-08-01
Status
Active (not recruiting)
Treatment
Mannitol
in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery
Arms:
Group M
Ringer's Lactate
similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery.
Arms:
Group C
Size
60
Primary endpoint
Time to extubation
1st 2 hour post-surgery
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The aim of this study is to test, whether mannitol infusion in will affect recovery pattern?', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-05-06

1 organization