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Introduction <p>Minor oral surgeries done under local anesthesia can be quite traumatic to the patient; thus, the use of conscious sedation can improve patient comfort, reduce stress levels, provide better pain management, smoother surgical experiences, and better recovery. Combinations of ketamine-dexmedetomidine and midazolam-pentazocine were used as conscious sedation regimens, and they have unique strengths and weaknesses. Evaluating the sedation effects of ketamine-dexmedetomidine versus midazolam-pentazocine in maxillofacial surgeries is crucial for refining anesthetic practices. Therefore, this study aimed to determine the ideal combination of pharmacological sedative regimens for enhancing conscious sedation among patients undergoing minor oral surgical procedures. </p> Materials and Methods <p>The current parallel arm trial was conducted at our institution from July 2024 to January 2025. The study consisted of 104 normotensive adults in the age range of 18–60&#xa0;years who underwent minor oral surgeries under conscious sedation in the dental hospital. In this double-blinded trial, one group was given an intervention of Ketamine-Dexmedetomidine combination (Group I) and the other group was given a Midazolam-Pentazocine combination (Group II) before undergoing minor oral and maxillofacial surgical procedures. The vitals during the pre-anesthetic evaluation such as blood pressure (BP), oxygen saturation and heart rate, and electrocardiography (ECG) were assessed before the procedure. During the procedure, all vitals were monitored every 10&#xa0;min. Pain was assessed every 10&#xa0;min during the surgery using an emoji-based visual analog scale (VAS) and the sedation score was assessed every 10&#xa0;min during the surgery by a modified Ramsay assessment scale. The data were tabulated and analyzed in SPSS software version 26.0. Independent samples ‘<i>t</i>’ test was used to assess the differences between the groups for the blood pressure, heart rate, and pain levels. Mann–Whitney <i>U</i> test was used to assess the differences between the groups in sedation levels. The significance level was kept at less than 0.05. </p> Results <p>There was no significant difference in age, weight, gender distribution, ASA grading, and duration of anesthesia between the groups. Group II had lower heart rate than Group I throughout the study period and the results were statistically significant. Group II had lower systolic arterial blood pressure than Group I throughout the study period. Although Group II had a comparatively lesser VAS score than Group I, the results were not statistically significant. There was a statistically significant difference in the sedation levels between the groups post-intervention with Group I exhibiting higher scores than Group II.</p> Conclusion <p>The Ketamine-Dexmedetomidine drug combination provided more effective sedation initially, with less respiratory depression than the Midazolam-Pentazocine drug combination for minor oral and maxillofacial surgical procedures. However, both sedation methods eventually offered comparable outcomes in terms of hemodynamic stability and pain management. </p>

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Conscious Sedation with Ketamine-Dexmedetomidine Versus Midazolam-Pentazocine in Enhancing Minor Oral Surgery Experience: A Parallel Arm Randomized Clinical Trial

  • 期刊论文

  • 发表日期：

    2025年6月20日

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  • Ramsesh Manohar Ram,
  • Preethi Jothi,
  • Saai Arun Sundar,
  • M. P. Santhosh Kumar,
  • M. Senthilmurugan

摘要

Introduction

Minor oral surgeries done under local anesthesia can be quite traumatic to the patient; thus, the use of conscious sedation can improve patient comfort, reduce stress levels, provide better pain management, smoother surgical experiences, and better recovery. Combinations of ketamine-dexmedetomidine and midazolam-pentazocine were used as conscious sedation regimens, and they have unique strengths and weaknesses. Evaluating the sedation effects of ketamine-dexmedetomidine versus midazolam-pentazocine in maxillofacial surgeries is crucial for refining anesthetic practices. Therefore, this study aimed to determine the ideal combination of pharmacological sedative regimens for enhancing conscious sedation among patients undergoing minor oral surgical procedures.

Materials and Methods

The current parallel arm trial was conducted at our institution from July 2024 to January 2025. The study consisted of 104 normotensive adults in the age range of 18–60 years who underwent minor oral surgeries under conscious sedation in the dental hospital. In this double-blinded trial, one group was given an intervention of Ketamine-Dexmedetomidine combination (Group I) and the other group was given a Midazolam-Pentazocine combination (Group II) before undergoing minor oral and maxillofacial surgical procedures. The vitals during the pre-anesthetic evaluation such as blood pressure (BP), oxygen saturation and heart rate, and electrocardiography (ECG) were assessed before the procedure. During the procedure, all vitals were monitored every 10 min. Pain was assessed every 10 min during the surgery using an emoji-based visual analog scale (VAS) and the sedation score was assessed every 10 min during the surgery by a modified Ramsay assessment scale. The data were tabulated and analyzed in SPSS software version 26.0. Independent samples ‘t’ test was used to assess the differences between the groups for the blood pressure, heart rate, and pain levels. Mann–Whitney U test was used to assess the differences between the groups in sedation levels. The significance level was kept at less than 0.05.

Results

There was no significant difference in age, weight, gender distribution, ASA grading, and duration of anesthesia between the groups. Group II had lower heart rate than Group I throughout the study period and the results were statistically significant. Group II had lower systolic arterial blood pressure than Group I throughout the study period. Although Group II had a comparatively lesser VAS score than Group I, the results were not statistically significant. There was a statistically significant difference in the sedation levels between the groups post-intervention with Group I exhibiting higher scores than Group II.

Conclusion

The Ketamine-Dexmedetomidine drug combination provided more effective sedation initially, with less respiratory depression than the Midazolam-Pentazocine drug combination for minor oral and maxillofacial surgical procedures. However, both sedation methods eventually offered comparable outcomes in terms of hemodynamic stability and pain management.