Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia
Schlüsselwörter
Abstrakt
Beschreibung
The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery. One hundred-sixty five ASA I-II adult patients between 18-65 years of age, undergoing elective major abdominal surgery with general anesthesia will be included in this double blinded, randomised, controlled study. Patients will randomly divided into equal (n=55) three groups. Preoperatively, one hour before surgery, patients will receive melatonin (6 mg) in group M, vitamin C (2 gr) in group C or placebo tablet in group P orally. A standard anesthetic protocol will be administered to all patients. At the end of surgery, postoperative pain control will be provided via a patient controlled analgesia (PCA) device including morphine in all groups. Hemodynamic parameters, pain, sedation, patient satisfaction, total morphine consumption, supplement analgesic requirement, incidence of nausea and vomiting and other side effects will be recorded at 5, 10, 30 min and 1, 2, 4, 6, 8, 12, 24 hr after surgery.
Termine
| Zuletzt überprüft: | 01/31/2019 |
| Zuerst eingereicht: | 11/10/2015 |
| Geschätzte Einschreibung eingereicht: | 12/21/2015 |
| Zuerst veröffentlicht: | 12/23/2015 |
| Letztes eingereichtes Update: | 02/11/2019 |
| Letztes Update veröffentlicht: | 02/14/2019 |
| Tatsächliches Startdatum der Studie: | 10/31/2014 |
| Geschätztes primäres Abschlussdatum: | 12/29/2019 |
| Voraussichtliches Abschlussdatum der Studie: | 12/29/2019 |
Zustand oder Krankheit
Intervention / Behandlung
Drug: Melatonin
Drug: Vitamin C
Other: Placebo
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Active Comparator: Oral Melatonin Tablet Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of melatonin (6 mg) or placebo tablet will be given one hour before the start of anesthesia. | |
| Active Comparator: Oral Vitamin C Tablet Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of vitamin C (2 gr) or placebo tablet will be given one hour before the start of anesthesia. | |
| Placebo Comparator: Oral Placebo Tablet Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia. |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | Inclusion Criteria: Patients undergoing elective major abdominal surgery with general anesthesia Exclusion Criteria: A history of psychiatric disorders, chronic pain syndromes, obstructive sleep apnea, severe asthma, chronic obstructive pulmonary disease, congestive heart failure, hepatic or renal failure, patients with pregnancy or in lactation period or a history of allergic reaction to any drugs |
Ergebnis
Primäre Ergebnismaße
1. morphine consumption at 24 hours after surgery.) [24 hour]
