Caesarean Section
Conditions
Keywords
Caesarean section, morphine, dexamethasone, nausea-vomiting, postoperative complications
Brief summary
The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine+Dexamethasone Combination added to bupivacaine in elective cesarean section under spinal anesthesia
Detailed description
The study will be designed as a double-blind, randomized clinical trial and will be conducted following approval by the local ethics committee. A total of 120 patients, aged 18-40 years, with an ASA physical status of II and scheduled for elective cesarean section, will be included. All patients will undergo standard preparation for spinal anesthesia. Two large-bore intravenous lines will be inserted in each patient upon arrival in the operating room. Participants will be randomly assigned to one of two groups (n = 60 per group) using sealed opaque envelopes. Group I (morphine group) will receive spinal anesthesia consisting of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL saline. Group II (morphine+dexamethasone group) will receive a mixture of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL (2 mg) dexamethasone. Intraoperative hemodynamic parameters (including age, height, and weight), ASA scores, postoperative complications (such as nausea, vomiting, and pruritus), and postoperative pain levels will be recorded and analyzed.
Interventions
PROCEDUREGroup morphine
Group Morphine: Spinal anesthesia will be applied to patients who will undergo caesarean section using a combination of 2 ml (10 mg) bupivacaine + 0.1 ml (100 mcg) morphine + 0.5 ml saline
PROCEDUREGroup morfin+dexamethasone
Group morfin+dexamethasone: Spinal anesthesia will be applied to patients who will undergo a caesarean section using a combination of 2 ml (10 mg) bupivacaine + 0.1 ml (100 mcg) morphine + 0.5 ml (2 mg) dexamethasone
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Spinal anesthesia will be administered to 120 pregnant patients scheduled for elective cesarean section, using either a combination of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL saline, or a combination of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL (2 mg) dexamethasone, depending on the group to which they are randomized.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for caesarean sections * Between 18-40 years * ASA II group * Those who will undergo spinal anesthesia * Those between 35-40 weeks of pregnancy * 1st and 2nd caesarean sections
Exclusion criteria
* Those who prefer general anesthesia * Those who are outside the age range of 18-40 * Those who are ASA III and above * Those with HT, DM, cardiac and respiratory diseases * Preeclampsia, eclampsia, HELLP * Those with a history of drug use that affects the cardiovascular system * Placenta Previa, Placenta Acreta, Placenta Acreta Those with a history of antiemetic or antidepressant drug use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea-vomiting | For 24 hours after surgery | The incidence of postoperative nausea and vomiting will be scored from 0 to 3. No nausea or vomiting attacks will be graded as 0, a nausea attack that resolves without treatment will be graded as 1, recurrent nausea attacks that resolve with treatment will be graded as 2, and persistent nausea or vomiting attacks will be graded as 3. |
| Postoperative itching | For 24 hours after surgery | The degree of pruritus will be assessed on a scale of 0 to 3, with 0 being categorized as no pruritus; 1 as mild pruritus; 2 as moderate pruritus; and 3 as severe pruritus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Mean Blood Pressure | Intraoperatively every 5 minutes | Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method. |
| Intraoperative Heart Rate | Intraoperatively every 5 minutes | Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method |
Contacts
Primary ContactNurettin KURT, assoc.Prof.
Backup ContactNurettin KURT, assoc.Prof.
Outcome results
None listed