Orthognathic SurgeryNCT06400355
Effect of Mannitol on Recovery Pattern After Orthognathic Surgery
A study testing Mannitol and Ringer's Lactate in people with Orthognathic Surgery, run by National Cancer Institute, Egypt at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- Mannitol and Ringer's Lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years
- ASA status I and II patient.
- No contraindication to use of mannitol.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthognathic Surgery
- Being tested
- Mannitol, Ringer's Lactate
- Keywords
- Mannitol, Recovery, Orthognathic Surgery, mandiblular fracture, maxillary protrusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery
Ringer's LactateDrug
similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Ringer's Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to extubation
Time to extubation which is defined as time from cessation of inhalation anesthetic to extubation
Measured: 1st 2 hour post-surgery
Secondary outcomes (3)
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).
Measured: 1st 2 hour postoperative
Time between anesthesia termination and discharge from PACU
Time between anesthesia termination and discharge from PACU
Measured: 1st hour 2hours postoperative
Urine output
Urine output
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2024
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of this study is to test, whether mannitol infusion in will affect recovery pattern?
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Sponsor
- Investigators
- Ahmed M Soliman, Principal investigator, National Cancer Institute Cairo universityMahmoud M kaml, Principal investigator, National Cancer Institute Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400355
- Sponsor's protocol ID
- RC1-3-2024
- Status last verified
- Jul 2024
- First submitted
- 21 Apr 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mannitol on Recovery Pattern After Orthognathic Surgery, a Prospective Randomized Double Blind Controlled Study.
- ClinicalTrials.gov ID
- NCT06400355
- Acronym / sponsor ID
- RC1-3-2024
- Conditions
- Orthognathic Surgery
- Keywords
- Mannitol, Recovery, Orthognathic Surgery, mandiblular fracture, maxillary protrusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The aim of this study is to test, whether mannitol infusion in will affect recovery pattern?
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Drug: Mannitolin which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery. |
| Group C | Active comparator | Drug: Ringer's Lactatesimilar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-65 years
- ASA status I and II patient.
- No contraindication to use of mannitol.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mannitolin which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery | Drug | Group M |
| Ringer's Lactatesimilar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery. | Drug | Group C |
Primary outcome
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
3 secondary outcomes
Quality of Recovery-15 (QoR-15)
Time frame: 1st 2 hour postoperative
Time between anesthesia termination and discharge from PACU
Time frame: 1st hour 2hours postoperative
Urine output
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Undecided. Till publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Soliman principal investigator
National Cancer Institute Cairo university
Mahmoud M kaml principal investigator
National Cancer Institute Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mannitol and Ringer's Lactate in people with Orthognathic Surgery, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to extubation (time frame: 1st 2 hour post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.