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The goal of this clinical trial is to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering in females undergoing caesarean section. The main question it aims to answer is: which route is more efficacious in preventing shivering.
Researchers will compare IV pethidine and intrathecal pethidine to see their effects on post spinal shivering, their effects on hemodynamic stability, nausea, vomiting, and sedation.
This study will be a single blinded, randomized, prospective controlled study. After obtaining written informed consents, 86 patients of American Society of Anesthesiologists physical status II, aged 20-40 years old, undergoing spinal anesthesia for elective cesarean section will be investigated at El-Shatby University Hospital.
The patients will be randomized into two groups of n=43 each using a computer-generated sequence. Allocation concealment will be done using sealed envelope technique. Depending on the group allocation either to receive IV Pethidine 0.5mg/kg (Group A n=43 patients) as premedication mixed into 10 ml isotonic saline slowly IV or intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5% (Group B n=43 patients). SA will be given at either L3-L4 or L4-L5 in the sitting position by the anesthetist using 22-25-gauge Quincke spinal needles. Patients will be covered with drapes but not actively warmed. 10mg ephedrine will be given if the patient becomes hypotensive (hypotension is defined as a decrease in MAP of >20% from the baseline). 0.5 mg atropine IV will be given if HR less than 50 beats/min. Rescue 4 mg ondansetron IV will be given for vomiting episodes. Room temperature will be maintained about 21 - 24ºC during the perioperative period in the OR and in the PACU, using temperature control system. The presence of shivering will be observed and graded after spinal injection by using Tsai and Chu Scale.
The following parameters will be measured:
The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering. The secondary aims will be to assess the effect of different routes of administration of the drug on hemodynamic stability, nausea, vomiting, and sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVGroup | Active Comparator | This group will receive IV 0.5mg/kg Pethidine as premedication mixed into 10 ml normal saline slowly IV |
|
| Intrathecal Group | Active Comparator | This group will receive intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pethidine Hydrochloride 50 Mg/mL Solution for Injection | Drug | Pethidine will be administered intravenously in group A 0.5 mg/kg as premedication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shivering incidence | The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence of shivering | every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively |
| Onset of shivering | The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the onset of shivering | every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively |
| Duration of shivering | The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the duration of shivering | every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively |
| Shivering intensity | The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the intensity of shivering, using the Tsai and Chu Scale The intensity of shivering using Tsai and Chu scale is measured as follows: 0: no shivering
| every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic stability | The secondary outcome is to assess the effect of different routes of administration of the drug on hemodynamic stability, by measuring the heart rate and blood pressure | at baseline and every 5 minutes after administration of the drug for 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes in the first 2 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Body Temperature | Body temperature will be measured using an axillary thermometer | before administration of the drug, then every 15 minutes till the end of surgery and every 30 minutes for 2 hours postoperatively |
Inclusion Criteria:
-
Exclusion Criteria:
Pregnant females undergoing caesarean section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mai A El-Sayed, Lecturer of Anesthesia | Contact | 00201287459922 | m_mohamed165@alexmed.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El-Shatby University Hospital | Recruiting | Alexandria | Alexandria Governorate | Egypt |
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| Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally | Drug | 0.2 mg/kg pethidine in trathecally will be administered with bupivacaine 0.5% in group B |
|
| Incidence of vomiting | The secondary outcome is to assess the effect of different routes of administration of the drug on incidence of vomiting | from administration of spinal till 2 hours postoperatively |
| Incidence of sedation | The secondary outcome is to assess the effect of different routes of administration of the drug on incidence of sedation | from administration of spinal till 2 hours postoperatively |
| ID | Term |
|---|---|
| D008614 | Meperidine |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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