Dosage of Epidural Morphine in Elderly Patients
Kata kunci
Abstrak
Deskripsi
Acute postoperative pain is a common complaint for several days after surgery. However, acute postoperative pain remains even more under controlled in elderly patients, especially those with cognitive impairment and malignancy. Geriatric population is reported to be at higher risk for unwanted side effects from analgesic treatments compared to younger patients due to different major risk factors such as: decline in organ function, polypharmacy, pharmacokinetics, drug sensitivity, and frailty. Despite of the higher risk of opioids, especially morphine, causing toxicity and adverse effect; they are still the cornerstone treatment of severe acute postoperative pain. Morphine in those patients is very likely to cause toxicity because of accumulation of its active metabolites compared to other opioids with fewer or no active metabolites. Epidural morphine is an effective route for an effective drug. Furthermore, unwanted side effects with neuraxial opioids are minor and managed easily. Regarding clinical outcomes, clinical studies showed a lot of improvements associated with postoperative opioid analgesia. Now, there is a clinical necessity to achieve the best management of acute postoperative pain in elderly patients with the least possibility of adverse side effects. We aim in this randomized, assessor blinded, clinical trial at Assuit University to determine the optimum dose of epidural morphine for the highest control of acute postoperative pain in geriatrics who are planned to have lower abdominal cancer surgery.
tanggal
Terakhir Diverifikasi: | 02/29/2020 |
Pertama Dikirim: | 03/18/2020 |
Perkiraan Pendaftaran Telah Dikirim: | 03/18/2020 |
Pertama Diposting: | 03/19/2020 |
Pembaruan Terakhir Dikirim: | 03/18/2020 |
Pembaruan Terakhir Diposting: | 03/19/2020 |
Tanggal Mulai Studi Sebenarnya: | 03/19/2020 |
Perkiraan Tanggal Penyelesaian Utama: | 12/30/2020 |
Perkiraan Tanggal Penyelesaian Studi: | 06/29/2021 |
Kondisi atau penyakit
Intervensi / pengobatan
Drug: Group M1.5
Drug: Group M0
Drug: Group M3
Drug: Group M4.5
Tahap
Kelompok Lengan
Lengan | Intervensi / pengobatan |
---|---|
Placebo Comparator: Group M0 | Drug: Group M0 Normal saline will be given epidurally. |
Active Comparator: Group M1.5 | Drug: Group M1.5 Morphine Sulphate, 1.5 mg will be given epidurally. |
Active Comparator: Group M3 | Drug: Group M3 Morphine Sulphate, 3 mg will be given epidurally. |
Active Comparator: Group M4.5 | Drug: Group M4.5 Morphine Sulphate, 4.5 mg will be given epidurally. |
Kriteria kelayakan
Usia yang Layak untuk Belajar | 65 Years Untuk 65 Years |
Jenis Kelamin yang Layak untuk Belajar | All |
Menerima Relawan Sehat | Iya |
Kriteria | Inclusion Criteria: 1. Men and women aged ≥ 60 years, who are planned to undergo lower abdominal cancer surgery. 2. Surgeries via infra-umbilical abdominal incision is considered eligible. Exclusion Criteria: 1. Patient refusal. 2. Patients who are morbidly obese (body mass index ≥ 40 kg/m2). 3. Those with contraindications to neuraxial analgesia. |
Hasil
Ukuran Hasil Utama
1. Total patient-controlled analgesia (PCA) morphine sulphate (MS) consumption. [72 hours]
Ukuran Hasil Sekunder
1. Pain-intensity measured using visual analog scale (VAS) [72 hours]
2. Ramsay sedation scale (RSS). [72 hours]
3. Nausea, vomiting and pruritis scale [72 hours]