Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections

NCT05991466 | Completed Phase 4

• 1 other identifier: MD-172-2021
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison to intrathecal dexmedetomidine.

Conditions

The Quality of Recovery (ObsQOR-11)

Outcome Measures

Primary Outcomes (1)

• Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative.

  The mothers will be asked to rate each recovery item with an 11-point numerical Likert scale (0 = strongly negative; 10 = strongly positive).

  24 hours postoperative

Secondary Outcomes (12)

• Time of first request of analgesia in hours

  within 24 hours postoperative

• Ramsay sedation scale

  1, 2, 4, 6, 8, 12 and 24 hours

• Intra operative non-invasive mean blood pressure

  within 24 hours postoperative

• Intra operative heart rate

  within 24 hours postoperative

• Visual Analogue Scale

  1, 2, 4, 6, 8, 12 and 24 hours postoperative

Study Arms (3)

Group(A)

ACTIVE COMPARATOR

Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg and TAP block will be performed with 30 ml 0.25% bupivacaine in each side.

Drug: Dexmedetomidine

Group (B)

ACTIVE COMPARATOR

Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine10-12 mg and TAP block will be performed with 50 mcg Dexmedetomidine added to 30ml 0.25% bupivacaine in each side.

Drug: Dexmedetomidine

Group (C)

ACTIVE COMPARATOR

Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg added to 5 mcg dexmedetomidine. TAP block will be performed with 30ml 0.25% bupivacaine in each side.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT\&PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests. Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block.

Group (B); Group (C); Group(A)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be full-term pregnant females
• ASA classification I or ll.
• Aged between 18 and 40 years.
• Singleton pregnancy

You may not qualify if:

• Refusal of block.
• Bleeding disorders (platelets count \<150,000; INR\>1.5; PC\<60%).
• wounds or infection at the puncture site.
• Known allergy to local anesthetic drugs.
• Contraindications to neuroaxial block.
• Contraindications to TAP block..

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 5, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)