Effect of Mannitol on Recovery Pattern After Orthognathic Surgery, a Prospective Randomized Double Blind Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to extubation
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •ASA status I and II patient.
- •No contraindication to use of mannitol.
排除标准
- •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.
研究组 & 干预措施
Group M
in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery.
干预措施: Mannitol (Drug)
Group C
similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery
干预措施: Ringer's Lactate (Drug)
结局指标
主要结局
Time to extubation
时间窗: 1st 2 hour post-surgery
Time to extubation which is defined as time from cessation of inhalation anesthetic to extubation
次要结局
- Urine output(24 hours postoperative)
- Time between anesthesia termination and discharge from PACU(1st hour 2hours postoperative)
- Quality of Recovery-15 (QoR-15)(1st 2 hour postoperative)