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临床试验/NCT07370181
NCT07370181进行中(未招募)3 期

Ketamine Irrigation Analgesia: For Controlling Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月30日最近更新:
干预措施

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Systemic inflammatory response via Neutrophil-to-lymphocyte ratio (NLR)

研究概览

简要总结

Patients will be assigned randomly to two groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 60 patients will be allocated in two groups (of 30 patients each) to receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N) or 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.

详细描述

The anesthetic technique will be standardized for all groups. Anesthesia will be induced with propofol 2 mg.kg-1, fentanyl 1 µg.kg-1 and rocuronium 0.6 mg/kg1for muscle relaxation. The size of the cuffed endotracheal tube will be selected according to the patient's age. Anesthesia and muscle relaxation will be maintained with 2% sevoflurane in a 50% oxygen/air mixture and 0.1 mg/kg rocuronium at fixed intervals. All patients will receive volume-cycled mechanical ventilation in ventilator settings that maintained normocarbia. Intra-operatively, patients will receive IV paracetamol 15 mg/kg and 10 mL/kg infusions of normal saline. Hemodynamic data (HR and MBP) will be monitored during the intraoperative period but recorded at the end of surgery before drug irrigation (T0), after extubation (T1), at postoperative care unit PACU admission (T2), then 30 min (T3), 1 hour (T4) and 2 hours (T5). Blood glucose will be measured using a point-of-care device (ACCU-CHEK©, Roche Pharmaceuticals, Basel, Switzerland) before the start of irrigation (T0), at PACU admission (T1), then after 12 hours (T2) and 24 hours (T3) to assess the effect of study drugs on the stress response.

At the end of the procedure, the residual neuromuscular blockade will be reversed with standard doses of neostigmine and atropine. Patients will be extubated awake in the recovery position and transported to the Post Anesthesia Care Unit (PACU). The anesthesia time (time in minutes from induction of anesthesia till its discontinuation) and time to extubation (time in minutes from the discontinuation of anesthesia till extubation) will be recorded. After fulfilling the criteria for full recovery, patients will be transferred to the ward.

Postoperative pain was assessed at rest and at movement, using a 0-10 cm VAS pain scale, where 0=no pain and 10=the worst pain imaginable. According to the degree of pain given by the patient, the classification of severity was done as follows: No pain = 0, mild pain=1-3, moderate pain= 4-6, and severe pain ≥7. The pain was treated with a bolus of pethidine 1 mg/kg when the reported VAS pain scale is ≥ 4. The score was assessed at 0 (PACU admission), 1, 2, 4, 12, and 24 hours after surgery.

The time to first request rescue analgesia and the total consumption of postoperative rescue analgesics will be recorded. Any perioperative adverse events will be treated and recorded such as hypotension, bradycardia, desaturation (SpO2% < 92%), and postoperative vomiting.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with age ≥18 years of ASA I-II who will be scheduled for elective laparoscopic cholecystectomy under general anesthesia.

排除标准

  • History of congenital heart disease
  • Hypertension
  • Developmental delay, or
  • Allergy to study drugs

研究组 & 干预措施

Group N

Placebo Comparator

Patients will receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N)

干预措施: Normal saline (Drug)

Group K

Experimental

Patients will receive 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.

干预措施: Ketamine (Drug)

结局指标

主要结局

Systemic inflammatory response via Neutrophil-to-lymphocyte ratio (NLR)

时间窗: 24 hours (One reading preoperative as a baseline and a second reading 24 hours postoperatively).

Evaluation of the anti-inflammatory effect of intraperitoneal ketamine irrigation by measuring changes in the Neutrophil-to-Lymphocyte Ratio (NLR). NLR is calculated by dividing the absolute neutrophil count by the absolute lymphocyte count from a standard complete blood count (CBC).

The total consumption of rescue analgesics

时间窗: 24 hours

The total consumption of postoperative rescue analgesics was recorded from the time to first request rescue analgesia to patient discharge after 24 h.

次要结局

  • The VAS pain score(24 hours)
  • the time to first request for rescue analgesics(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Makram Soliman

Associate Professor

Assiut University

研究点 (1)

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