Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- onset of defecation
研究概览
简要总结
Laparoscopic cholecystectomy is now very common procedure to remove the gall bladder from abdomen. After this procedure many patients suffer from the non functioning of intestine and stomach which is very common after any abdominal surgery. Many efforts tried to reduce this non functioning period or postoperative ileus but non of them was superior later on. The investigators want to evaluate the role of chewing gum for reducing postoperative ileus. The investigators hypothesis is that Chewing gum after laparoscopic cholecystectomy reduces postoperative ileus and sugared preparations are more effective to reduce it.
详细描述
Laparoscopic cholecystectomy is considered now the gold standard for gall stone disease. Postoperative ileus after any abdominal surgery is common complication, it is considered as physiological response and is the main cause of postoperative abdominal pain, discomfort and increased duration of hospital stay. Postoperative ileus (POI) may last up to 5 days after uncomplicated abdominal surgery. Activity of small intestine returns within 24 hours while stomach and large intestine take up to 36 and 72 hours to regain motility.3 The use of early feeding, medications like cisapride etc. have been used to reduced POI but none of them has been significantly useful on further research work.
Gum chewing after abdominal surgery reduces the duration of POI, pain and discomfort. Gum chewing also reduces halitosis, dental caries, elevates mood and reduces stress which are additional benefits. Many studies proved that the chewing gum has only placebo effect after surgery in adults and children. Sugar-free chewing gum has been focused mainly in studies. Perioperative role of glucose intake has shown many benefits like reducing insulin resistance.
In this study the investigators wanted to evaluate the role of chewing gum in reducing POI in laparoscopic cholecystectomy and further exploration to see the whether which chewing gum is more beneficial, sugar-free or sugared. If the study proves the beneficial effect of chewing gum then the investigators can have better management of patients postoperatively by sugared chewing gum which is readily available and inexpensive.
After meeting inclusion and exclusion criteria, All patients were given Tab. Midazolam 7.5 mg PO at night before surgery and received same standard general anesthesia with endotracheal intubation. Inj. Midazolam IV 0.7 mg/kg was given 45 min before surgery as premedication. Anesthesia was induced by propofol (2.5 mg/kg) after 3 minutes of preoxygenation. Muscle relaxation was achieved by atracuium (0.5 mg/kg). Anesthesia was maintained with sevoflurane (2.5 vol %) and oxygen in air mixture (0.50 ratio). Ventilation was controlled mechanically and end tidal normocapnia was maintained by keeping pCO2 at 35-38 mmHg.
Following medications were given to patients during the process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
干预措施: Tab. Midazolam 7.5 mg (Drug)
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
干预措施: Inj. Midazolam 0.7mg/kg 45 min before surgery (Drug)
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
干预措施: Inj. Propofol 2.5mg/kg (Drug)
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
干预措施: Inj. Atracurium 0.5 mg/kg (Drug)
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
干预措施: Sevoflurane 2.5 vol % (Drug)
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
干预措施: Inj. Cefuroxime 1.5 g IV (Drug)
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
干预措施: Inj. Ketorolac 30 mg IV (Drug)
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
干预措施: Inj. Zantac 50mg IV (Drug)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: sugared chewing gum (Other)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: Tab. Midazolam 7.5 mg (Drug)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: Inj. Midazolam 0.7mg/kg 45 min before surgery (Drug)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: Inj. Propofol 2.5mg/kg (Drug)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: Inj. Atracurium 0.5 mg/kg (Drug)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: Sevoflurane 2.5 vol % (Drug)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: Inj. Cefuroxime 1.5 g IV (Drug)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: Inj. Ketorolac 30 mg IV (Drug)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: Inj. Midazolam 0.7mg/kg 45 min before surgery (Drug)
sugar free chewing gum
sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started.
干预措施: Inj. Zantac 50mg IV (Drug)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: sugar free chewing gum (Other)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: Tab. Midazolam 7.5 mg (Drug)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: Inj. Propofol 2.5mg/kg (Drug)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: Inj. Atracurium 0.5 mg/kg (Drug)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: Sevoflurane 2.5 vol % (Drug)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: Inj. Cefuroxime 1.5 g IV (Drug)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: Inj. Ketorolac 30 mg IV (Drug)
sugared chewing gum
sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
干预措施: Inj. Zantac 50mg IV (Drug)
结局指标
主要结局
onset of defecation
时间窗: 4 hours after surgery until patient defecated. an expected average of 24 hours.
the patients were asked when they passed stool first time after surgery. that time was noted in terms of hours after surgery.
onset of hunger
时间窗: 4 hours after surgery until patient feels first feeling of hunger. an expected average of 12 hours.
the patients were asked when they felt first feeling of hunger. this time was noted in terms of hours after surgery.
onset of bowel movements
时间窗: 4 hours after surgery until the bowel sounds are present. an expected average of 10 hours.
the patients were examined by resident doctor hourly after surgery for presence of bowel sounds by a stethoscope. Additional all patient were asked when they felt first bowel sounds. the time at which the first bowel activity was present was noted in terms of hours after surgery.
onset of flatus passing
时间窗: 4 hours after surgery until patient passes flatus. an expected average of 18 hours.
the patients were asked when they passed first flatus. this time was noted in terms of hours after surgery.
次要结局
- time of surgery(skin incision to skin closure time of surgery. an expected average of 1 hour)
研究者
Dr.Fazal hussain Shah
General Surgery Resident
Benazir Bhutto Hospital, Rawalpindi