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IRCT2014031717039N1 IRCT 2014-07-30 Vice chancellor for research, Jahrom University of Medical Sciences Comparison of Midazolam and Propofol on nausea and vomiting induced during cesarean section with spinal anesthesia Clinical trial of Comparison of low-dose Midazolam and Propofol on nausea and vomiting induced during operation, in pregnant women undergoing cesarean section with spinal anesthesia 2013-06-22 anticipated 42 Complete https://irct.ir/trial/15774 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Nausea and vomiting. Intervention 1: Patients were divided into two groups A and B randomly by Random Allocation software. They did not receive any special medicine before entering operation room. Before starting surgery, patients received 7 ml/kg Ringer serum and then While patients got 65 mg Lidocain 5% for spinal anesthesia, group A were injected 1.5mg Midazolam. At the end of surgery patients were transferred to the recovery room. They were kept in recovery room for at least 1 hour. Nausea and vomiting of patients were measured based on their feelings in 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia by a self-instructive questionnaire. The patients and the investigator did not have any information about the drugs used. Intervention 2: Patients were divided into two groups A and B randomly by Random Allocation software. They did not receive any special medicine before entering operation room. Before starting surgery, patients received 7 ml/kg Ringer serum and then While patients got 65 mg Lidocain 5% for spinal anesthesia, group B were injected 2cc (20mg) Propofol. At the end of surgery patients were transferred to the recovery room. They were kept in recovery room for at least 1 hour. Nausea and vomiting of patients were measured based on their feelings in 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia by a self-instructive questionnaire. The patients and the investigator did not have any information about the drugs used.
public Marjan Jaladat
7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
Jahrom Iran (Islamic Republic of) 7414846199 +98 79133404059 Marjan.Jaladat@gmial.com Jahrom University of Medical Sciences scientific Hassan Zabetian
7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
Jahrom Iran (Islamic Republic of) +98 79 1334 0405 Dr.Jaladat@jums.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Written formal consent for operation, Pregnant women aged 15 to 60 years old, Class 1 and 2 ASA, Cesarean section candidate, No physical or mental illness, No consumption of Sedative, Antidepressant, Sleeping or Psychotropic medicine. Exclusion Criteria: Weight more than 100 kg, Age more than 60 or less than 15, Drug or alcoholic abusers, Treatment by Anti depressant, sleeping and psychotropic pills, Inadequate cooperation with investigator to assess nausea and vomiting after operation, Hospitalization in ICU after operation, Any background of Propofol or Midazolam sensitivity, Need for additional treatment, Becoming ill after surgery, Increased anesthesia level, Respiratory distress, Patients of class 3 and 4 of ASA, Hemodynamic disorders 15 years 60 years Female k91.9 Postprocedural disorder of digestive system, unspecified Prevention Prevention Patients were divided into two groups A and B randomly by Random Allocation software. They did not receive any special medicine before entering operation room. Before starting surgery, patients received 7 ml/kg Ringer serum and then While patients got 65 mg Lidocain 5% for spinal anesthesia, group A were injected 1.5mg Midazolam. At the end of surgery patients were transferred to the recovery room. They were kept in recovery room for at least 1 hour. Nausea and vomiting of patients were measured based on their feelings in 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia by a self-instructive questionnaire. The patients and the investigator did not have any information about the drugs used. Patients were divided into two groups A and B randomly by Random Allocation software. They did not receive any special medicine before entering operation room. Before starting surgery, patients received 7 ml/kg Ringer serum and then While patients got 65 mg Lidocain 5% for spinal anesthesia, group B were injected 2cc (20mg) Propofol. At the end of surgery patients were transferred to the recovery room. They were kept in recovery room for at least 1 hour. Nausea and vomiting of patients were measured based on their feelings in 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia by a self-instructive questionnaire. The patients and the investigator did not have any information about the drugs used. Nausea and Vomiting. Timepoint: 1 ,3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia. Method of measurement: Have or not have with the Questionnaire made by Investigator. Blood pressure. Timepoint: 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia. Method of measurement: Sphygmomanometer. Pulse. Timepoint: 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia. Method of measurement: Pulse oximetry. Respiratory Rate. Timepoint: 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia. Method of measurement: Counting breaths by investigator. O2 Saturation of arterial blood. Timepoint: During surgery and recovery. Method of measurement: Pulse oximetry. Apgar. Timepoint: 1 and 5 minutes after the birth. Method of measurement: Assessment by investigator by Apgar criteria. Vice chancellor for research, Jahrom University of Medical Sciences Approved 2013-05-29 Ethics Committee of Jahrom University of Medical Sciences 7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom Iran (Islamic Republic of)