Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery
Evaluation of the Effectiveness of Intravenous Dexamethasone in Preventing Adverse Effects of Spinal Anesthesia in Parturients Undergoing Cesarean Delivery
The goal of this clinical trial is to evaluate the effectiveness of intravenous dexamethasone in preventing adverse effects of spinal anesthesia and prolonging postoperative analgesia in parturients undergoing elective cesarean delivery.
The main questions it aims to answer are:
Does intravenous dexamethasone reduce the incidence of post-spinal hypotension?
Does intravenous dexamethasone reduce the incidence of postoperative nausea and vomiting (PONV)?
Does intravenous dexamethasone prolong the duration of postoperative analgesia?
Researchers will compare intravenous dexamethasone (8 mg) to a placebo (0.9% saline) to see if dexamethasone effectively prevents post-spinal hypotension and PONV, and improves postoperative pain relief.
Participants will:
Receive an intravenous injection of either 8 mg dexamethasone or a placebo (2 mL 0.9% saline) prior to receiving spinal anesthesia.
Have their blood pressure recorded frequently (every minute for the first 20 minutes, then every 5 minutes until the completion of surgery).
Undergo sensory block assessment (via cold testing) and motor block evaluation (using the Bromage scale).
Have maternal glycemia and neonatal safety monitored for potential steroid-related adverse effects.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Ho Chi Minh
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Ho Chi Minh City、Ho Chi Minh、ベトナム、700000
- University Medical Center Ho Chi Minh City (UMC) - Campus 2
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age ≥ 18 years
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- American Society of Anesthesiologists (ASA) physical status classification of II-III
- Planned for elective cesarean delivery under spinal anesthesia
Exclusion Criteria:
- Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus
- Gestational hypertension or chronic hypertension
- Body mass index (BMI) ≥ 35 kg/m²
- Known allergy to dexamethasone
- Current long-term corticosteroid therapy
- Diagnosis of postpartum hemorrhage
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.
|
|
実験的：デキサメタゾン
|
Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Post-Spinal Hypotension
時間枠：From the induction of spinal anesthesia until the completion of surgery
|
The number of participants experiencing at least one episode of post-spinal hypotension.
Hypotension is defined as a decrease in systolic blood pressure of 20% or more from the baseline value.
Baseline blood pressure is defined as the mean value of three consecutive measurements taken 2 minutes apart, with a variation of less than 10%.
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are recorded every minute for the first 20 minutes after spinal anesthesia, and then every 5 minutes until the completion of surgery and transfer to the post-anesthesia care unit
|
From the induction of spinal anesthesia until the completion of surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Postoperative Nausea and Vomiting (PONV)
時間枠：From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)
|
The number of participants experiencing nausea, vomiting, or retching, or requiring rescue antiemetic treatment.
Rescue treatment is administered as intravenous ondansetron 4 mg or intravenous metoclopramide 10 mg.
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From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)
|
|
Duration of Postoperative Analgesia
時間枠：From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)
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The time elapsed from the administration of spinal anesthesia to the patient's first request for systemic rescue analgesic medication.
Rescue analgesia is administered when the patient complains of pain and records a Visual Analog Scale (VAS) score greater than 4 (on a scale of 0 to 10).
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From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 4667/UMP-BOARD
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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