Mental and Behavioural Disorders Nervous System Diseases Anaesthesia
Conditions
Interventions
Control Group
Sponsors
Ain Shams University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 18 years or older, physical status ASA I&II, with up to 12-week gestation, submitted to manual intrauterine aspiration for incomplete or retained abortion, participated in this randomized, double blind study.
Exclusion criteria
Exclusion criteria: patients with infected abortion or with psychiatric disorder on chronic medical treatment. Also, patients with pulmonary, hepatorenal, neuromuscular diseases body mass index over 30 kg/m2, usage of sedative drugs or substance abuse, any contraindications to regional anesthesia and finally emergency curettage for massive bleeding or hemodynamic instability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary outcome is mood changes which were assessed preoperatively and 2 h postoperatively with POMS-A to determine if there were differences in mood state that could be attributed to the interventional drug infused. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were: 1. Mean blood pressure and heart rate were measured preoperatively then every 5 min till end of the operation. Postoperatively, mean blood pressure, heart rate, were recorded every 30 minutes for 2 hours in PACU 2. Total dose of ketamine infused. 3. The duration of surgery in minutes. 4. Presence of psychedelic’ phenomenon [10] intraoperatively (during infusion) and/or postoperatively. It is a temporary altered state of consciousness that might be induced by ketamine infusion. The subjective phenomenon that might be reported included one or more of the following: perceptual disorders, a sense of detachment from their bodies (dissociation), a sense of relaxation or well-being. Hallucinations, if occurred would be treated with injecting 2 mg intravenous midazolam. 5. Presence of intraoperative (during infusion) and/or postoperative other side effects as headache & diplopia 6. Presence of intraoperative (during infusion) and/or postoperative nausea and vomiting (PONV) which was rated on a 4-point scale (0=no PONV, 1=Mild nausea, 2=Severe nausea, 3=Vomiting). If PONV scale was 2 or more, ondansetron 4mg was given intravenously. 7. The patient satisfaction was assessed postoperatively at the 2nd hour. Patient satisfaction were rated on a scale of 1 to 4 (1=perfect, 2=good, 3=moderate, 4=bad). 8. Assessment of postoperative pain was done with the aid of visual analogue scale (VAS) in which patients were requested to estimate their pain on vertical VAS 0–10 cm where (0) is marked as no pain and (10) is marked as the worst pain ever felt. [11]. This was recorded postoperatively at specific timings: every 30 minutes for 2 hours postoperatively. 30 mg ketorolac was given intravenously if VAS score was > or equal to 4 at any of the mentioned times (with a maximum total ketorolac dose of 60 mg). 9. Assessment of perioperative sedation level using Sedation scale using University of Michigan Sedation Scale (UMSS) [12] The UMSS as a measur | — |
Countries
Egypt
Contacts
Public ContactMohamed Abdulmohsen Abdulnaiem Ismaiel
Lecturer of Anesthesia Ain Shams University
Outcome results
None listed