Anxiety Clinical Trial
Official title:
The Effect of Melatonin on Anxiety and Sleep Quality in the Peri-Operative Course of Adults Undergoing Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study
The objective of this study is to evaluate the effect of melatonin on post operative sleeping quality, anxiety, and post-operative opioid requirements in adults post coronary artery bypass graft (CABG) surgery.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age from 40-60 years. - Both sexes. - Patients undergoing standard on-pump CABG with the same technique by the same surgical team. Exclusion Criteria: - Refusal of procedure or participation in the study by patients. - Patients with known history of allergy to one of study drugs - Patients taking psychiatric medications, CNS depressants, and hypnotic drugs. - Patients with neurological disorders stroke, intracranial hemorrhage and surgery. - Patients with a history of suffering from any sleep disorder. - Severe circulatory or respiratory disease. - Patients with obstructive sleep apnea. - Cognitive or psychiatric illness that leads to inability to cooperate, speak or provide informed consent |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of sleep | Sleep quality will be evaluated using the Groningen Sleep Quality Score (GSQS), The GSQS consists of 15 questions about the previous night's sleep, answered with Yes or No. | Five days postoperative | |
Secondary | Anxiety | The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire employed by clinicians to rate the severity of anxiety. This scale includes 14 items. Each consists of a number of symptoms, and the symptoms are graded on a scale of zero to four.
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. |
24 hours postoperative | |
Secondary | Opioid requirements | Postoperative analgesia in the ICU was carried out for both groups. All patients received IV fentanyl infusion (0.5ugm/kg/hr) with 15ug bouls if sudden rise in Heart rate or mean arterial blood pressure > 20% of base line to be stopped before extubation, after extubation Paracetamol 1gm was given every 8 hours for all patients, diclofenac 75mg /12hr. | 24 hours postoperative | |
Secondary | The degree of pain | The degree of pain will be assessed using numerical rating scale (NRS) requires for sternal pain, the patient to rate their pain on a defined scale from 0-10 where 0 is no pain and 10 is the worst pain) measured at time intervals: 30 minutes, 6hours, 12hours, and 24h after extubation. If NRS > 4 rescue analgesia will be given in form of IV morphine0.05mg /kg. | 24 hours postoperative |
Status | Clinical Trial | Phase | |
---|---|---|---|
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