Effect of Mannitol on Recovery Pattern After Orthognathic Surgery

NCT06400355 | Active Not Recruiting DMC

• 1 other identifier: RC1-3-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthognathic Surgery

Keywords

Mannitol; Recovery; Orthognathic Surgery; mandiblular fracture; maxillary protrusion

Outcome Measures

Primary Outcomes (1)

• Time to extubation

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

  1st 2 hour post-surgery

Secondary Outcomes (3)

• Quality of Recovery-15 (QoR-15)

  1st 2 hour postoperative

• Time between anesthesia termination and discharge from PACU

  1st hour 2hours postoperative

• Urine output

  24 hours postoperative

Study Arms (2)

Group M

ACTIVE COMPARATOR

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

Drug: Mannitol

Group C

ACTIVE COMPARATOR

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

Interventions

Mannitol DRUG

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

Group M

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.

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years
• ASA status I and II patient.
• No contraindication to use of mannitol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead
• faculty of medicine, Benha university: collaborator

Study Sites (1)

Benha Univesity

Cairo, 11796, Egypt

Location

MeSH Terms

Interventions

Mannitol; Ringer's Lactate

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ahmed M Soliman

  National Cancer Institute Cairo university

  PRINCIPAL INVESTIGATOR

• Mahmoud M kaml

  National Cancer Institute Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The aim of this study is to test, whether mannitol infusion in will affect recovery pattern?

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: May 6, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

EG (1)