Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering
NCT ID: NCT03675555
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2018-03-01
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patient's refusal, duration of surgery more than 120 min, obesity with body mass index (BMI) \>35 kg/m2, generalized infection or localized infection at level of blockade, neurologic disease, coagulation disorder, patients with hypo- or hyperthyroidism, cardiopulmonary disease, psychological disorders, a need for blood transfusion during surgery, an initial body temperature \>38.0C or \<36.0C, a known history of alcohol or substance abuse, or receiving vasodilators, or medications likely to alter thermoregulation excluded the patient from the study.
Randomization and Blinding This study was designed to be a randomized, placebo-controlled, double-blinded parallel study. Following enrollment, patients were randomized into 3 equal groups;
1. The M (Mirtazapine) (Merta) group:(n=100) each patient received 30 mg Mirta tablet orally with sips of water and 100 ml 0.9% sodium chloride (normal saline \[NS\]) (IVI) over 15 min as a placebo for Dex 2 h preoperatively.
2. The D (Dexamethasone) (Dex) group: (n=100) each patient received a placebo tablet identical to Mirta tablet orally with sips of water and Dex 8 mg ampoule diluted in 100 ml 0.9% NS IVI over 15 min, 2 h preoperatively.
3. The C (Control) group: (n=100) each patient received the same placebo tablet identical to Mirta tablet orally with sips of water and 100 ml 0.9% NS IVI over 15 minas a placebo for Dex 2 h preoperatively.
Randomization was done using computer-generated table of random numbers in a 1:1 ratio in opaque and sealed envelope (SNOSE). The assigned treatment was written on a card and sealed in opaque envelopes consecutively numbered. These envelopes were opened just immediately before infusing the medication in the patient's room. The study drugs were prepared by the hospital pharmacy and follow-up of patients were conducted by anesthesia residents not involved in any other part of the study.
Study Protocol On arrival in the operating theatre, all patients had an inserted venous cannula. I.V. fluids were preheated to 37oC. No other warming device was used. Lactated Ringer's solution was warmed to 37 oC and was infused at 10 ml/kg over 30 min before spinal anesthesia. The infusion rate was reduced to 6 ml/ kg.
Subarachnoid anesthesia was instituted at either L3/4 or L4/5 interspaces. Hyperbaric bupivacaine, 5 mg /ml, 15 mg was injected using a 25 G Quincke spinal needle.
Supplemental oxygen (5 liter/ min) was delivered via a facemask during the operation. All patients were covered with one layer of surgical drapes over the chest, thighs, and calves during the operation and one cotton blanket over the entire body after operation. The operating and recovery rooms temperatures were maintained at 23-25°C with approximately 60% humidity.
Assessment parameters Heart rate, mean arterial pressure (MAP), and peripheral oxygen saturation were recorded using standard noninvasive monitors before intrathecal injection and thereafter at 5, 10, 15, 20 minutes then every 10 minutes to complete 90 minutes from the intrathecal injection.
Sensory levels were assessed by pinprick to determine the peak sensory level and time to two segment regression in minutes. Motor block were assessed by using Modified Bromage scale(16) (0 = no block 1 = hip block, 2 = hip and knee block, 3 = hip, knee, and ankle block) to determine the time to reach complete motor block and duration of motor blockade (minutes).
Sedation score was assessed with a four-point scale as per Filos et al.(17): 1: Awake and alert. 2: Somnolent, but responsive to verbal stimuli. 3: Somnolent, arousable to physical stimuli. 4: Unarousable.
Body temperature (axillary temperature) was recorded with an axillary thermometer. The ambient temperature was measured by a wall thermometer. The ambient temperature will be maintained at 25oC with constant humidity.
Shivering severity was assessed with a four-point scale (Badjatia et al):
1. None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall
2. Mild (Grade 1): shivering localized to the neck and/or thorax only
3. Moderate (Grade 2): shivering involved gross movement of the upper extremities (in addition to neck and thorax)
4. Severe (Grade 3): shivering involved gross movements of the trunk and upper and lower extremities.
Shivering was assessed immediately before the block and every 10 minutes till the first 90 min (end point of the study) after the completion of the subarachnoid drug injection (start point of the study). Grade 2 or 3 of shivering score was regarded failure of prophylaxis and meperidine 25 mg IV was administered.
Side-effects, including hypotension (defined as a decrease in MAP of more than 20% from baseline or a decrease of arterial blood pressure below 90 mmHg and baseline MAP was calculated from three measurements taken on the ward before surgery) was treated by crystalloid infusion and if necessary ephedrine 5 mg IV was administered. The amount of ephedrine given in each group was recorded. Bradycardia was considered if the heart rate \<50 beats/min and was treated with IV atropine (0.01mg/kg). Respiratory depression (RR \< 12 bpm), incidence of nausea and vomiting during early 2 hours postoperatively were recorded. IV granisetron (1 mg) was given in case of vomiting or after 2 successive episodes of nausea.
Patients' satisfaction with shivering prophylaxis was done by asking the patient to answer the question, "How would you rate your experience after the surgery?" using a 7-point Likert verbal rating scale and acceptable satisfaction score of the patient being 5-7.
3-Analysis of Data:
The collected data were coded, tabulated, and statistically analyzed using IBM SPSS statistics (Statistical Package for Social Sciences) software version 22.0, IBM Corp., Chicago, USA, 2013.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
M (Mirtazapine) (Merta) group:(n=100)
Mirtazapine
Each patient received 30 mg Mirta tablet orally with sips of water and 100 ml 0.9% sodium chloride (normal saline \[NS\]) (IVI) over 15 minutes as a placebo for Dex solution 2 hours preoperatively.
D (Dexamethasone) (Dex) group: (n=100)
Dexamethasone phosphate
Each patient received a placebo tablet identical to Mirta tablet orally with sips of water and Dex 8 mg ampoule diluted in 100 ml 0.9% NS IVI over 15 minutes, 2 hours preoperatively.
C (Control) group: (n=100)
Placebo
Each patient received a placebo tablet identical to Mirta tablet orally with sips of water and 100 ml 0.9% NS IVI over 15 minutes as a placebo for Dex solution 2 h preoperatively.preoperatively.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mirtazapine
Each patient received 30 mg Mirta tablet orally with sips of water and 100 ml 0.9% sodium chloride (normal saline \[NS\]) (IVI) over 15 minutes as a placebo for Dex solution 2 hours preoperatively.
Dexamethasone phosphate
Each patient received a placebo tablet identical to Mirta tablet orally with sips of water and Dex 8 mg ampoule diluted in 100 ml 0.9% NS IVI over 15 minutes, 2 hours preoperatively.
Placebo
Each patient received a placebo tablet identical to Mirta tablet orally with sips of water and 100 ml 0.9% NS IVI over 15 minutes as a placebo for Dex solution 2 h preoperatively.preoperatively.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* of the American Society of Anesthesiologists (ASA) physical status I or II
* and underwent gynecological surgeries under spinal anesthesia.
* A written informed consent was obtained from all patients to participate in the study.
Exclusion Criteria
* duration of surgery more than 120 min,
* obesity with body mass index (BMI) \>35 kg/m2,
* generalized infection or localized infection at level of blockade,
* neurologic disease,
* coagulation disorder,
* patients with hypo- or hyperthyroidism,
* cardiopulmonary disease,
* psychological disorders,
* a need for blood transfusion during surgery,
* an initial body temperature \>38.0C or \<36.0C,
* a known history of alcohol or substance abuse,
* or receiving vasodilators, or medications likely to alter thermoregulation
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ain Shams University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr.Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ibrahim Mamdouh Esmat
Heliopolis, Cairo Governorate, Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Esmat IM, Elsayed AM, El-Hariri HM, Ashoor TM. A Randomized Controlled Trial for Prevention of Postspinal Anesthesia Shivering in Gynecological Surgeries: Mirtazapine vs. Dexamethasone. Anesthesiol Res Pract. 2022 Mar 9;2022:5061803. doi: 10.1155/2022/5061803. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R 47 / 2018
Identifier Type: -
Identifier Source: org_study_id