]>
IRCT20230813059138N1 IRCT 2023-08-23 University of Sousse, Faculty of Medicine Ibn Al Jazzar Spinal anesthesia additives Ketamine versus Tramadol as an adjuvant to Bupivacaine in Spinal anesthesia 2023-08-26 anticipated 120 Complete https://irct.ir/trial/72038 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple, individual randomization will be occur by a person who is not considered as a participant in this clinical trial by using special sample randomization software by Microsoft Excel, randomization will occur on a 1:1:1 ratio of bupivacaine to bupivacaine plus ketamine to bupivacaine plus tramadol. the person will give a random sequence to the solutions of study , and this preparation will send to a second person who does not know the exact solution. All bupivacaine , bupivacaine plus ketamine, and bupivacaine plus tramadol solutions are unknown and will be keep in a box. The participants and the researcher will not be able to distinguish the type of solution that will administer to the patient. Directly after administering the solution the observer will records all required variables data, Although he also do not know the exact administered solution. At the full end of each single patient data collection, the person who previously had gave a random sequence will open the codes to records the real administered solution on patient’s special form of data, Blinding description: explain the plan for colleagues previously. when the patient came he took an ID which is previously allocated randomly in groups by using Microsoft excel. the study solution was prepared by an anesthetist who did not involved in data collection. the observation and collecting of data done by other anesthetist. 3 additives in spinal anesthesia. Intervention 1: Control group: receiving 2ml of hyperbaric bupivacaine 0.5%. After Fasting period of 6 hours, patient received intravenous preload of 10 ml/kg of either N/S or ringer solution. No premedication where given because the effects of these drugs may intervene with some of result that observed such as sedation or nausea and/or vomiting and other variables. patient in sitting position acupuncture given with midline technique under aseptic environment at the level of L3/L4, orifice oriented cephalad needle G25 was used. The study solution injected at the same adequate speed for all the patient then convert the patient to supine position. The volume of study's liquid increased to 3 ml by normal saline for all control and intervention groups. Intervention 2: Intervention group 1: receiving 2ml of hyperbaric bupivacaine 0.5% plus ketamine (25 mg). After Fasting period of 6 hours, patient received intravenous preload of 10 ml/kg of either N/S or ringer solution. No premedication where given because the effects of these drugs may intervene with some of result that observed such as sedation or nausea and/or vomiting and other variables. patient in sitting position acupuncture given with midline technique under aseptic environment at the level of L3/L4, orifice oriented cephalad needle G25 was used. The study solution injected at the same adequate speed for all the patient then convert the patient to supine position. The volume of study's liquid increased to 3 ml by normal saline for all control and intervention groups. Intervention 3: Intervention group 2: receiving 2ml of hyperbaric bupivacaine 0.5% plus tramadol (25 m). After Fasting period of 6 hours, patient received intravenous preload of 10 ml/kg of either N/S or ringer solution. No premedication where given because the effects of these drugs may intervene with some of result that observed such as sedation or nausea and/or vomiting and other variables. patient in sitting position acupuncture given with midline technique under aseptic environment at the level of L3/L4, orifice oriented cephalad needle G25 was used. The study solution injected at the same adequate speed for all the patient then convert the patient to supine position. The volume of study's liquid increased to 3 ml by normal saline for all control and intervention groups. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: 8 months after publication To whom: Researcher, and academic institute. Conditions: the data will be available for supporting academic study to improve the study that needs these data like meta analysis study. Where to obtain: Email: ammar.hoom88@gmail. cellphone: 009647705787925 How to obtain: Introducing them selves, and give logical reason behind needing this data will be enough to supply them. Comments:
public Dr. Mohamad Kahloul
Avenue Mohamad Karoui 4002 Sousse B.P:126
Sousse Tunisia 4000 +216 73 222 600 famso@famso.rnu.tn University of Sousse, Ibn Al Jazzar College of medicine scientific DRr Mohamad Kahloul
Avenue Mohamad Karoui 4002
Sousse Tunisia 4000 +216 73 222 600 famso@famso.rnu.tn University of Sousse, Ibn al Jazzar college of medicine Iraq Female Age between (16-45 years) ASA class 1 or 2 elective open unilateral ovarian cystectomy 16 years 45 years Female spine deformity bleeding tendency neurological diseases history of scorpion bite patient disapproval N83.20 Ovarian cyst, unilateral. unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: receiving 2ml of hyperbaric bupivacaine 0.5%. After Fasting period of 6 hours, patient received intravenous preload of 10 ml/kg of either N/S or ringer solution. No premedication where given because the effects of these drugs may intervene with some of result that observed such as sedation or nausea and/or vomiting and other variables. patient in sitting position acupuncture given with midline technique under aseptic environment at the level of L3/L4, orifice oriented cephalad needle G25 was used. The study solution injected at the same adequate speed for all the patient then convert the patient to supine position. The volume of study's liquid increased to 3 ml by normal saline for all control and intervention groups. Intervention group 1: receiving 2ml of hyperbaric bupivacaine 0.5% plus ketamine (25 mg). After Fasting period of 6 hours, patient received intravenous preload of 10 ml/kg of either N/S or ringer solution. No premedication where given because the effects of these drugs may intervene with some of result that observed such as sedation or nausea and/or vomiting and other variables. patient in sitting position acupuncture given with midline technique under aseptic environment at the level of L3/L4, orifice oriented cephalad needle G25 was used. The study solution injected at the same adequate speed for all the patient then convert the patient to supine position. The volume of study's liquid increased to 3 ml by normal saline for all control and intervention groups. Intervention group 2: receiving 2ml of hyperbaric bupivacaine 0.5% plus tramadol (25 m). After Fasting period of 6 hours, patient received intravenous preload of 10 ml/kg of either N/S or ringer solution. No premedication where given because the effects of these drugs may intervene with some of result that observed such as sedation or nausea and/or vomiting and other variables. patient in sitting position acupuncture given with midline technique under aseptic environment at the level of L3/L4, orifice oriented cephalad needle G25 was used. The study solution injected at the same adequate speed for all the patient then convert the patient to supine position. The volume of study's liquid increased to 3 ml by normal saline for all control and intervention groups. Primary outcome were the onset and duration of both sensory and motor block, and the duration of spinal analgesia. Timepoint: 3 days after intervention. Method of measurement: sensory block by pinprick, while the motor block observed by modified bromage score. The secondary outcome were, nausea, vomiting, sedation, shivering, heart rate, mean arterial pressure. Timepoint: directly after intervention till 3 days after intervention. Method of measurement: inspection (visually) observation. University of Sousse, Faculty of Medicine Ibn Al Jazzar Approved 2022-07-04 Ethics committee of research's in Diyala health directorate- Iraqi ministry of health 7 Nissan Ave., main Ave., Baquba city., Diyala governorate., Repoblic of Iraq Baquba Diyala Iraq