Effects of Three Different Doses of Intrathecal Dexmedetomidine Added to Bupivacaine on effectiveness of Subarachnoid Block in Elective Caesarean Sections: A Prospective Randomized Double-Blind Study

To compare the effects of three different doses (5 µg, 7.5 µg, and 10 µg) of intrathecal dexmedetomidine added to hyperbaric bupivacaine on the effectiveness of subarachnoid block in patients undergoing elective caesarean section.

“A prospective, randomized, double-blind, placebo-controlled clinical trial with four parallel groups.”

The study will be conducted at the Department of Anaesthesia, DHQ Hospital Batkhela, Malakand, Pakistan. Eligible female patients undergoing elective cesarean section under spinal anesthesia will be randomized into four groups. Perioperative data including block characteristics, analgesia duration, hemodynamic changes, sedation, and adverse effects will be collected and analyzed

Inclusion Criteria • Female patients aged 18–40 years. • ASA physical status I or II. • Scheduled for elective caesarean section under spinal anaesthesia • Willing to provide informed consent Exclusion Criteria • Emergency caesarean sections. • Known fatal anomalies. • Contraindications to spinal anaesthesia (e.g., infection at puncture site, coagulopathy). • Known allergy to dexmedetomidine or bupivacaine. • Significant maternal medical conditions (cardiovascular, neurological, hepatic, or renal disorders).

Intervention Group 1 (Control group) Intervention Group 2 (Dexmedetomidine 5 µg) Intervention Group 3 (Dexmedetomidine 7.5 ) Intervention Group 4 (Dexmedetomidine 10 µg

Primary outcomes include onset and duration of sensory and motor block and postoperative analgesia. Secondary outcomes include hemodynamic changes, adverse effects, sedation, and neonatal Apgar scores

Participants were randomly assigned to one of four study groups using computer-generated block randomization with a 1:1:1:1 allocation ratio. The randomization sequence was prepared by an independent investigator, and group assignments were concealed in sequentially numbered, opaque, sealed envelopes until participant enrollment.

Participants and outcome assessors were blinded to group allocation. The intrathecal study drug was prepared by an independent anesthetist not involved in patient management or outcome assessment. All study solutions had identical appearance and volume, ensuring that participants and the anesthesiologist administering the drug remained unaware of treatment allocation until completion of data collection.

De-identified Clinical Trial Dataset and Study Documents” Details: “The dataset will include anonymized demographic characteristics, clinical observations, sensory and motor block parameters, duration of analgesia, hemodynamic measurements, adverse effects, sedation scores, and neonatal Apgar scores collected during the study. Additional documents may include the study protocol, statistical analysis plan, and final study results. All shared data will be de-identified to protect participant confidentiality

The data will become available after completion of the study, final data analysis, and publication of the results. The data may be available for a period of 5 years after publication upon reasonable request and approval from the principal investigator

The data/documents will be available to qualified researchers, academic institutions, and scientific reviewers upon reasonable request and approval from the principal investigator and relevant ethical authorities. Access will be provided only for legitimate research purposes while maintaining participant confidentiality.

The data/documents may be used for scientific research, academic purposes, systematic reviews, and secondary analyses related to obstetric anesthesia, spinal anesthesia, and intrathecal dexmedetomidine. Requests will be evaluated based on scientific merit, ethical approval (if required), and assurance of maintaining participant confidentiality.”

The data/documents can be obtained from the principal investigator of the study upon reasonable request. Access will be provided after review and approval of the request, in accordance with ethical requirements and data confidentiality policies.

A formal request should be submitted to the principal investigator describing the purpose of data use. The request will be reviewed for scientific validity, ethical compliance, and confidentiality requirements. After approval, de-identified data/documents will be shared through a secure method with the requester

No additional comments. All shared data and documents will be de-identified to ensure participant confidentiality and will be made available only for legitimate scientific and academic purposes following ethical approval and the consent of the principal investigator.