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Nalbuphine Dosing and Its Impact on Anxiety and Depression in Ectopic Pregnancy Surgery
Sponsor: Chengdu Jinjiang Maternity and Child Health Hospital
Summary
This prospective, randomized, controlled study aims to evaluate the impact of different doses of nalbuphine on anxiety and depression in patients undergoing surgery for ectopic pregnancy. Ectopic pregnancy, which occurs in approximately 2% of all pregnancies, often requires surgical intervention, leading to potential psychological distress such as anxiety and depression in affected women. Effective postoperative pain management is essential to enhance recovery and reduce emotional disturbances. The study will involve 165 eligible patients diagnosed with ectopic pregnancy at Jinjiang District Maternal and Child Health Hospital. Participants will be randomly assigned to three groups, each receiving a different concentration of nalbuphine combined with metoclopramide for postoperative analgesia. The primary outcome will focus on changes in anxiety and depression scores measured on postoperative day three, while secondary outcomes will assess pain levels, the use of patient-controlled analgesia (PCA), the necessity for rescue analgesics, and the occurrence of adverse reactions. Sample size calculations suggest that at least 165 participants are required to achieve adequate statistical power. Data will be analyzed using SPSS 25.0 software, with results expected to provide insights into the effectiveness of nalbuphine in improving postoperative recovery and mental health in women experiencing ectopic pregnancy. The study has received ethical approval and is funded by the Chengdu Medical Research Projects (No. 2023465, 2022548, and 2023304).
Official title: Effects of Different Doses of Nalbuphine on Anxiety and Depression in Patients Undergoing Ectopic Pregnancy Surgery: A Prospective, Randomized, Controlled Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
165
Start Date
2025-06-20
Completion Date
2025-10-30
Last Updated
2025-06-08
Healthy Volunteers
No
Interventions
Nalbuphine 0.20mg/ml(total 30 mg)
In this group, participants will receive an intravenous infusion of Nalbuphine at a concentration of 0.20 mg/ml, which delivers a total of 30 mg over the course of 48 hours. Additionally, 10 mg of Metoclopramide will be administered to manage potential postoperative nausea. This intervention aims to assess the analgesic efficacy and its subsequent effect on psychological outcomes, specifically anxiety and depression, in patients undergoing surgery for ectopic pregnancy.
Nalbuphine 0.27mg/ml(total 40 mg)
Participants assigned to this group will be treated with an intravenous infusion of Nalbuphine at a concentration of 0.27 mg/ml, resulting in a total dosage of 40 mg administered during the 48-hour postoperative period. They will also receive 10 mg of Metoclopramide to mitigate nausea and vomiting. This intervention is designed to evaluate the effectiveness of this dose in pain management and its influence on anxiety and depression levels post-surgery.
Nalbuphine 0.33mg/ml(total 50 mg)
In this group, subjects will receive Nalbuphine at a concentration of 0.33 mg/ml, totaling 50 mg, delivered through intravenous infusion for 48 hours. Along with this, 10 mg of Metoclopramide will be included to address potential postoperative discomfort. This intervention seeks to explore how this higher concentration impacts pain relief and subsequent psychological effects, specifically targeting anxiety and depression following ectopic pregnancy surgery.